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@health.qld.gov.au.

Cardiology Clinical Research Centre Clinical Trials, Investigator Driven Research and Authorised Prescriber

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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