Clinical trials (cardiology)
The Cardiology Clinical Research Centre is dedicated in the coordination and conduct of multiple phases of multi-centred, international and national clinical trials. These include investigator initiated studies on the treatment, management and follow up care of patients with a range of chronic and acute cardiac conditions particularly severe aortic stenosis, severe mitral regurgitation, heart failure, acute coronary syndrome, conduction disturbances and hyperlipidemia. The main focus for the clinical trials being undertaken in the centre is innovative new technologies in transcatheter approach heart procedures including first-in-man research.
Cardiology Clinical Research Centre also coordinates and conducts clinical trials and investigator initiated research whilst upholding the principles of the Declaration of Helsinki in accordance with the guidelines for International Conference of Harmonisation and Good Clinical Practice. The Centre also complies with the International Organisation for Standardisation (ISO) 14155 for Medical Device Trials.
The majority of the Cardiology Clinical Research Centre activities are focused on patient recruitment and retention. All cardiology patients are considered potential research patients. This allows patients to have opportunity to access new therapies and devices which are only available through clinical trials.
For more information on clinical trials, please contact us on (07) 3139 4711 or tpch-cardiology-research
Cardiology Clinical Research Centre Clinical Trials, Investigator Driven Research and Authorised Prescriber
| Date | Sponsor | Trial Title | Description | Principal Investigator | Trial status | Lead Site for HREC |
|---|---|---|---|---|---|---|
| 2014 – 2016 | Authorised Prescriber | ABSORB BVS | The Absorb Bioresorbable Vascular Scaffold is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (12 mm, 18 mm, 28 mm) with reference vessel diameters > 2.0 mm and < 3.8 mm. | Prof Darren Walters Dr Chris Raffel Dr Matthew Pincus, Dr Brendan Bell Dr Karl Poon Dr Alex Incani |
Closed | |
| 2013 – 2014 | Abbott Vascular | ABSORB III | A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions | Prof Darren Walters | Closed | |
| 2014 – Present | Abbott Vascular | ABSORB IV | A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions | Prof Darren Walters | Follow Up | |
| 2008 – 2010 | Medtronic | ACQUIRE | Australian CareLink Quality and Impact of RemotE Follow-Up Evaluation | Archived | ||
| 2016 – Present | Reid Healthcare | ACURATE neo™ | A Multicentre, Non-Randomised Controlled Study of the Symetis ACURATE neo™ Valve Implantation Using TransFemoral Access in an Australian Population | Prof Darren Walters | Recruiting | |
| Medtronic | Adaptive CRT | Medtronic Adaptive CRT Clinical Study | Dr Russell Denman | Archived | Single Site submission | |
| Medtronic | ADVISA MRI | Medtronic Advisa MRI Study | Dr Russell Denman | Archived | Single Site submission | |
| 2012 – 2014 | An investigator-initiated trial sponsored by Abbott Vascular Inc. | APPOSE | Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus from Cobalt versus Platinum Alloy Platforms (APPOSE Trial) | Prof Darren Walters | Closed | |
| 2008 – 2013 | Bristol Myers Squibb | ARISTOTLE | EC 2707- PROTOCOL: CV185030 – A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation (ARISTOTLE) | Prof Darren Walters | Archived | Single Site submission |
| 2008 – 2012 | Janssen-Cilag | ATLAS 2 | EC 28107: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome. | Prof Darren Walters | Archived | Single Site submission |
| Medtronic | ATTAIN PERFORMA | Attain Performa™ Quadripolar Lead Study | Dr Russell Denman | Archived | ||
| 2008 – 2013 | Biosensors Interventional Technologies | BEACON II | B.E.A.C.O.N. II : A Multi-Centre Registry of BioMatrix drug-eluting stent in Asia-Pacific Countries. | Prof Darren Walters | Closed | Single Site submission |
| 2011 – 2013 | BioTronik | BIOLUX | Treatment of Bifurcation Lesions with the BIOTRONIK Pantera Lux Drug Eluting Balloon (BIOLUX I) | Prof Darren Walters | Archived | Single Site submission |
| 2013 – present | Investigator Initiated | CAAN-AF | Cardiac Resynchronisation Therapy (CRT) And AV Node ablation trial in AF | Dr Haris Haqqani | Recruiting | Single Site submission |
| 2017 – present | ACOR | Cardiac Devices Registry | Australiasian Cradiac Outcomes Registry – Cardiac Devices Registry | Prof Darren Walters | Awaiting RGO approval | |
| 2017 – present | ACOR | Cardiac Procedures Registry | Australiasian Cradiac Outcomes Registry – Cardiac Procedures Registry | Prof Darren Walters | Awaiting RGO approval | |
| 2016 – Present | St Jude Medical | CardioMEMS | CardioMEMSTM HF System Post-Approval Study | Dr Scott McKenzie | Recruiting | Single Site submission |
| 2008 – 2013 | Cardiomind | CARE II | A Prospective, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Performance of the CardioMind Coronary Stent Systems for Treatment of Stenotic Lesions in Small Diameter Native Coronary Arteries | Prof Darren Walters | Archved | Single Site submission |
| 2008 – 2011 | Merck Sharpe & Dohme | CARS | Clopidogrel and Aspirin Resistance Study | Prof Darren Walters | Archived | Single Site submission |
| 2015 – Present | Edwards Lifesciences | CENTERA | Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve | Prof Darren Walters | Follow Up | Multicentre – Lead site |
| 2008 – 2012 | The Medicines Co. | CHAMPION | A Clinical Trial Comparing Cangrelor To Clopidogrel In Subjects Who Require Percutaneous Coronary Intervention | Archived | Single Site submission | |
| 2017 – Present | Edwards Lifesciences | CLASP | Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study | Prof Darren Walters | Recruiting | Multicentre – Lead site |
| 2011 – 2014 | Coherex Wavecrest | Coherex LAA | A Multi-centre study to evaluate the safety and efficacy of the Coherex Left Atrial Appendage Occlusion System | Prof Darren Walters | Archived | Single Site submission |
| Westmead Millenium Institute | COMFORT | Concept of Optimal Management of Ventricular Fibrillation or Very Fast Ventricular Tachycardia | Dr Russell Denman | Archived | Single Site submission | |
| 2009 – 2016 | Investigator Initiated Registry | Concordance | HREC/10/QPCH/84: Cooperative National Registry of Acute Coronary Care Guideline Adherence and Clinical Events | Prof Darren Walters | Closed | Muticentre – Submission |
| 2008 – Present | Medtronic | COREVALVE | EC 2801: An Investigator Initiated Clinical Trial using Percutaneous Aortic Valve Replacement (PAVR) with the CoreValve ReValving™ System and CoreValve International ReValving™ Registry: | Prof Darren Walters | Closed | Single Site submission |
| 2013 – 2015 | Authorised Prescriber | COREVALVE AP | The valve is known as the Medtronic CoreValve? System or Corevalve Evolut for patients with severe symptomatic native aortic valve stenosis who undergo Percutaneous Aortic Valve Replacement (PAVR). It is distributed by Medtronic Austrasia Pty Ltd. This is not currently approved for use by the Therapeutic Goods Administration (TGA) in Australia. Its use in this case is therefore under Special Access Scheme from TGA Authorised Prescribers. | Prof Darren Walters Dr Andrew Clarke Dr Peter Tesar A/Prof Con Aroney |
Device Approved | |
| 2009 – 2011 | Datascope Corp. | CRISP AMI | Study of Mechanical Left Ventricular Unloading with Counterpulsation to reduce Infarct Size Pre-PCI for Acute MI | Prof Darren Walters | Archived | Single Site submission |
| 2016 – Present | Medpace | Dal-GenE | A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS) | Dr Chris Raffel | Recruiting | |
| 2008 – 2011 | ParmaNetic | DANUBE | A Phase IIa, Multi-Center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DNB-001 in Patients with Angina Pectoris and Moderate Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention | Prof Darren Walters | Archived | Single Site submission |
| 2008 – 2011 | Johnson & Johnson | E Cypher Select | A Multi centre post market surveillance | Prof Darren Walters | Archived | Single Site submission |
| 2012 – 2015 | Authorised Prescriber | Edwards AP | The valve is known as the Edwards SAPIENTM Transcatheter Aortic Valve. It is distributed by an Australian company called Edwards Lifesciences Pty Ltd. The SAPIENTM Transcatheter Aortic Valve is approved for use in Europe but it is not currently approved for use by the Therapeutic Goods Administration (TGA) in Australia. Its use in this case is therefore under Special Access Scheme from TGA Authorised Prescribers. | Prof Darren Walters Dr Andrew Clarke Dr Peter Tesar A/Prof Con Aroney |
Device Approved | |
| 2008 – 2011 | Medtronic | ENDEAVOUR | A PROSPECTIVE, MULTICENTRE, SINGLE ARM REGISTRY TO EVALUATE THE SAFETY AND EFFICACY OF THE MEDTRONIC AVE ABT-578 COATED DRIVER CORONARY STENT SYSTEM IN SUBJECTS WITH DE NOVO LESIONS OF THE NATIVE CORONARY ARTERIES | Prof Darren Walters | Archived | Single Site submission |
| 2013 – 2015 | St Jude Medical | ENHANCE | Efficacy of the PreseNce of Right Ventricular Apical Pacing Induced Ventricular DyssyncHrony as a Guiding PArameter for BiveNtricular PaCing in PatiEnts with Bradycardia and Normal Ejection Fraction | Dr Haris Haqqani | Closed | Multicentre – Lead site |
| 2012 – Present | St Jude Medical | EnligHTN II | IntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN | Prof Darren Walters | Follow Up | Multicentre – Lead site |
| 2010 – 2016 | Boston Scientific | EVOLVE | A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System for the Treatment of a De Novo Atherosclerotic Lesion | Prof Darren Walters | Closed | Single Site submission |
| 2012 – Present | Boston Scientific | EVOLVE II | A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion(s) | Prof Darren Walters | Follow Up | |
| 2014 – 2015 | Boston Scientific | EVOLVE II QCA | A Prospective, Multicenter Trial to Assess the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY™ Stent System) for the Treatment of Atherosclerotic Lesion(s) | Prof Darren Walters | Archived | Lead site |
| 2015 – Present | Reva Medical Inc | FANTOM II | Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold | Prof Darren Walters | Follow Up | |
| 2016 – Present | Boston Scientific | FAST | FAST Feasibility Study: Fully Absorbable Scaffold Feasibility Study | Prof Darren Walters | Follow Up | |
| 2014 – Present | Imperial College London | FLAIR | Prospective, multi-center, double blind, randomised study to test the safety of deferral of stenting in physiological non-significant lesions in a clinical population of intermediate stenoses using iFR and FFR | Prof Darren Walters | Follow Up | |
| 2010 – 2012 | National Heart, Lung & Blood Institute (NHLBI) | FREEDOM | EC 2626: Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel disease | Dr Nick Bett | Closed | Single Site submission |
| 2013 – Present | Bayer Healthcare | GADACAD2 | Multicenter open-label study to evaluate efficacy of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known or suspected CAD by a blinded image analysis | Dr Christian Hamilton-Craig | Closed | Single Site submission |
| 2017 – | AMGEN | GALACTIC | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction | Dr Scott McKenzie | Recruiting | |
| 2015 – 2016 | Janssen-Cilag | GEMINI | A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects with Acute Coronary Syndrome | Prof Darren Walters | Closed | |
| 2013 – 2015 | AMGEN | GLAGOV | A Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of AMG 145 Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization | Prof Darren Walters | Closed | |
| 2015 – Present | AMGEN | GLAGOV OPEN LABEL EXTENSION | A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab | Prof Darren Walters | Follow Up | |
| 2013 – Present | Global Genomics | GLOBAL | Genetic Loci and the Burden of Atherosclerotic Lesions. | Dr Christian Hamilton-Craig | On hold | |
| 2014 – Present | ECRI/Cardiolysis | GLOBAL LEADERS | COMPARATIVE EFFECTIVENESS OF 1 MONTH OF TICAGRELOR PLUS ASPIRIN FOLLOWED BY TICAGRELOR MONOTHERAPY VERSUS A CURRENT-DAY INTENSIVE DUAL ANTIPLATELET THERAPY IN ALL-COMERS PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH BIVALIRUDIN AND BIOMATRIX FAMILY DRUG-ELUTING STENT USE. | Dr Chris Raffel | Follow Up | |
| 2013 – 2014 | St Jude Medical | ILUMIEN I | Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I | Dr Chris Raffel | Archived | Single Site submission |
| 2012 – Present | Boston Scientific | INGEVITY | Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study | Dr Russell Denman | Follow Up | Single Site submission |
| 2004 | Investigator Initiated Trial | Investigation of HITTS | Prospective Screening for Heparin-induced Thrombocytopenia in Cardiac Transplant Patients: Incidence, Outcomes and Recommendations | Prof Darren Walters | Archived | Single Site submission |
| 2008 – 2011 | Eisai | LANCELOT | A randomised double-blind Placebo-controlled Study of the safety and tolerability of E555, and its effects on clinical events and biomarkers in patients with non ST segment Elevation and acute coronary syndrome | Dr Nick Bett | Archived | Single Site submission |
| 2014 – Present | GlaxoSmithKline | LATITUDE | Phase III trial comparing losmapimod vs placebo x 12 weeks on the incidence of MACE in subjects with ACS (NSTEMI and STEMI) | Dr Chris Raffel | Archived | |
| 2013 – 2016 | Biosensors Europe | LEADERS FREE | A PROSPECTIVE RANDOMIZED COMPARISON OF THE BIOFREEDOMTM BIOLIMUS A9TM DRUG COATED STENT VERSUS THE GAZELLE™ BARE METAL STENT IN PATIENTS AT HIGH RISK FOR BLEEDING | Prof Darren Walters | Closed | Single Site submission |
| 2015 – Present | St Jude Medical | LEADLESS II | A Safety and effectiveness trial for a leadless pacemaker system | Dr Russell Denman | Follow Up | |
| 2014 – Present | Investigator Initiated Registry | MARS REGISTRY | This is an Asia-Pacific multi-centre international observational registry of patients with mitral regurgitation treated with the MitraClip | Prof Darren Walters | Ongoing | Single Site submission |
| 2012 – 2014 | Abbott Vascular | Mitra Clip | MitraClip System ANZ Clinical Trial. A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand. | Prof Darren Walters | Closed out | Single Site submission |
| 2014 – Present | Investigator Initiated Trial | MITRA CLIP MRI ECHO | Quantitative Assessment of Post-implant Function by MRI and Echo | Dr Christian Hamilton-Craig | On hold | Single Site submission |
| 2013 – 2014 | Servier | MODIFY | Effects of ivabradine on plaque burden, morphology and composition in patients with clinically indicated coronary angiography. A randomised double-blind placebo-controlled international multicentre study. | Dr Chris Raffel | Archived | |
| 2010 – 2011 | Investigator Initiated Registry/ Monash |
MOODCARE | An implementation trial of a telephone-based care management program targeting depression for patients following myocardial infarction | Prof Darren Walters | Archived | Single Site submission |
| 2016 – Present | Armaron Bio | NP202 for Treatment after a Heart Attack | A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Left Ventricular Systolic Dysfunction following Myocardial Infarction. | Prof Darren Walters | Recruiting | |
| 2008 – 2011 | New York University | OAT Trial | Occluded Artery Trial | Prof Darren Walters | Achived | |
| 2011 – 2014 | Investigator Initiated Trial | OCT Registry | MGH Optical Coherence Tomography Registry | Dr Chris Raffel | Closed | Single Site submission |
| 2010 – 2014 | Investigator Initiated Trial | OCT v FFR | Validation of Intravascular Optical Coherence Tomography Parameters With Fractional Flow Reserve for Assessment of Coronary Stenosis Severity | Dr Chris Raffel | Closed | Single Site submission |
| 2014 – Present | Sanofi Aventis | ODYSSEY | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome | Dr Chris Raffel | Follow Up | |
| 2012 – 20013 | Investigator initiated trial supported by Biosensors International, Singapore | OPTIMA | OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF INTIMAL TISSUE AND MALAPPOSITION | Prof Darren Walters | Archived | Single Site submission |
| 2013 – Present | Authorised Prescriber | Pantera Lux | Coronary Angioplasty with Pantera Lux Paclitaxel Releasing Balloon Catheter | Prof Darren Walters Dr Chris Raffel Dr Matthew Pincus, Dr Brendan Bell Dr Karl Poon Dr Akshay Mishra |
Recruiting | |
| 2017 – Present | Novartis | PARADISE MI | A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction | Dr Scott McKenzie | Recruiting | |
| 2017 – Present | Edwards Lifesciences | PARTNER 3 | A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific Aortic Stenosis Requiring Aortic Valve Replacement | Prof Darren Walters | Recruiting | Multicentre – Lead site |
| 2014 – Present | Janssen-Cilag | PIONEER | An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention | Prof Darren Walters | Closed | |
| 2009 – 2013 | Boston Scientific | PLATINUM QCA | A prospective Multi-Centre Trial to assess an Everolimus – Eluting Coronary Stent System (PROMUS Element) | Prof Darren Walters | Achived | Single Site submission |
| 2012 – 2013 | Boston Scientific | PLATINUM WORKHORSE | A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to two De Novo Coronary Artery Lesions | Prof Darren Walters | Archived | Single Site submission |
| 2013 – Present | St Jude Medical | PORTICO I | International long-term follow-up study of patients implanted with a PORTICO™ valve | Prof Darren Walters | Recruiting | |
| 2016 – Present | St Jude Medical | PORTICO IDE | PorticoTM Re-sheathable transcatheter Aortic Valve System US IDE Trial | Prof Darren Walters | Recruiting | |
| 2008 – 2011 | St Jude Medical | PRECISE Registry | PFO closure and cryptogenic stroke registry | Prof Darren Walters | Archived | Single Site submission |
| 2012 – Present | George Institute | PROTECT ICD | Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-defibrillator Implantation to Prevent Tachyarrhythmia following Acute Myocardial Infarction | Dr Russell Denman | Recruiting | |
| Medtronic | Protect Pace | EC2664 The protection of left ventricular function during right ventricular pacing. Does Right Ventricular High-Septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing? | Dr Russell Denman | Closed | Single Site submission | |
| 2008 – 2013 | Medtronic | PROTECT PCI | An international study in which data will be collected of patients who are suitable for stenting and who will be treated with one or more drug eluting stents. | Prof Darren Walters | Closed | Single Site submission |
| 2014 – Present | Boehringer Ingelheim | REDUAL PCI | A prospective randomised, open label, blinded endpoint (PROBE) study to evaluate dual antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor with or without aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting | Prof Darren Walters | Follow Up | |
| 2017 – Present | Cardiac Dimensions | REDUCE FMR | The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System? in Reducing Functional Mitral Regurgitation (FMR) Associated with Heart Failure | Prof Darren Walters | Recruiting | |
| 2014 – Present | Corviva/ DC Devices |
REDUCE LAP-HF | A study to evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure | Dr Scott McKenzie | Follow Up | |
| 2017 – Present | Corvia | REDUCE LAP-HF REF RCT | Reduce Lap-HF Randomised Trial II: A study to evaluate the Corvia Medical, Inc. IASD? System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure | Dr Scott McKenzie | Recruiting | |
| 2012 – 2015 | Boston Scientific/Vessix | REDUCE-HTN | TReatment of rEsistant hypertension using a raDiofrequency percUtaneous transluminal angioplasty CathetEr | Prof Darren Walters | Closed | |
| 2012 – Present | Boston Scientific | REPRISE II | REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Evaluation of Safety and Performance | Prof Darren Walters | Follow Up | Single Site submission |
| 2015 – Present | Boston Scientific | REPRISE III | REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation | Prof Darren Walters | Recruiting | Single Site submission |
| 2014 – Present | Boston Scientific | REPRISE NG DS | REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LotuS™ ValvE with the Next Generation Delivery System | Prof Darren Walters | Follow Up | Single Site submission |
| 2008 – 2012 | Medtronic | RESOLUTE | The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions – The Medtronic RESOLUTE Clinical Trial | Prof Darren Walters | Archived | Single Site submission |
| 2014 – Present | Reva Medical Inc | RESTORE II | ReZolve2™ Sirolimus-Eluting Bioresorbable Coronary Scaffold | Prof Darren Walters | Closed | Single Site submission |
| 2013 – 2015 | Medtronic | REVEAL LINQ | The Reveal LINQ™ Usability Study will assess the functionality of the Reveal LINQTM device by assessing sensing performance and data transmission with the aim to support the market launch of the device | Dr Russell Denman | Archived | Single Site submission |
| 2015 – Present | Medtronic | REVELUTION | A Clinical Evaluation of the Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (Polymer-free DES Trial | Prof Darren Walters | Follow Up | |
| 2008 – 2011 | Janssen-Cilag | ROCKET | A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) with Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation. | Prof Darren Walters | Archived | Single Site submission |
| 2009 – 2012 | AstraZeneca | SATURN | Study of Coronary Atheroma by InTravascular Utrsound: Effect of Rosuvastatin Versus AtorvastatiN. A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease | Prof Darren Walters | Archived | Single Site submission |
| Biosense Webster | SMARTTOUCH | THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation | Dr Haris Haqqani | Archived | Multicentre – Lead site | |
| 2010 – Present | Edwards Lifesciences | SOLACE-AU | A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population (Transfemoral Approach) | Prof Darren Walters | Follow Up | Multicentre – Lead site |
| 2017 – Present | University of Alberta | Sodium HF | The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure | Haunnah Rheault | Recruiting | |
| 2009 – 2012 | GlaxoSmithKline | SOLSTICE | HREC/09/QPCH/112: A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers and infarct size in subjects with myocardial infarction without ST-segment elevation. (SOLSTICE) | Prof Darren Walters | Archived | Single Site submission |
| 2010 – 2012 | Edwards Lifesciences | SOURCE ANZ | Edwards SAPIEN™ Transcatheter Heart Valve Source ANZ Transpical Ascendra Introducer System | Prof Darren Walters | Archived | Single Site submission |
| 2009 – 2013 | Abbott Vascular | SPIRIT PRIME | A Clinical Evaluation of the XIENCE PRIME™ and XIENCE PRIME ™ LL Everolimus Eluting Coronary Stent System | Prof Darren Walters | Archived | Single Site submission |
| 2015 – Present | Tendyne | TENDYNE | Expanded Clinical Study of the Tendyne Mitral Valve System | Prof Darren Walters | Recruiting | |
| 2013 – Present | George Institute | TEXTMEDS | Text Messages to improve medication adherence and secondary prevention | Dr Christian Hamilton-Craig | Follow Up | |
| 2008 – 2012 | Schering Plough | TRACER | EC 2839: A Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA?CER) | Dr Nick Bett | Archived | Single Site submission |
| 2017 – present | 4TECG | TRICINCH | Feasibility Study of the Percutaneous 4Tech Tricinch Coil Tricuspid Repair System | Dr. Darren Walters | Recruiting | |
| 2011 – 2012 | Eli Lilly | TRIPLET (TAEH) | HREC/10/QPCH/44: TAEH: A Comparison of Platelet Inhibition Following a Prasugrel 60mg or Prasugrel 30mg Loading Dose With or Without Pre-treatment with a Clopidogrel Loading Dose in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention | Prof Darren Walters | Archived | Single Site submission |
| 2016 – Present | Merck Sharpe & Dohme | VICTORIA | VerICiguaT glObal study in subjects with heart failure with Reduced ejectIon frAction (VICTORIA) | Dr Scott McKenzie | Recruiting | |
| 2008 – 2012 | Abbott Vascular | ZOMAXX | A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx™ Drug-Eluting Coronary Stent System Compared to the TAXUS™ Express²™ Paclitaxel-Eluting Coronary Stent System in de novo Coronary Artery Lesions | Prof Darren Walters | Archived | Single Site submission |