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 

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

DateSponsorTrial TitleDescriptionPrincipal InvestigatorTrial statusLead Site for HREC
2014 - 2016Authorised PrescriberABSORB BVSThe 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 - 2014Abbott VascularABSORB IIIA Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery LesionsProf Darren WaltersClosed
2014 - PresentAbbott VascularABSORB IVA Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery LesionsProf Darren WaltersFollow Up
2008 - 2010MedtronicACQUIREAustralian CareLink Quality and Impact of RemotE Follow-Up EvaluationArchived
2016 - PresentReid HealthcareACURATE neo™A Multicentre, Non-Randomised Controlled Study of the Symetis ACURATE neo™ Valve Implantation Using TransFemoral Access in an Australian PopulationProf Darren WaltersRecruiting
MedtronicAdaptive CRTMedtronic Adaptive CRT Clinical StudyDr Russell DenmanArchivedSingle Site submission
MedtronicADVISA MRIMedtronic Advisa MRI StudyDr Russell DenmanArchivedSingle Site submission
2012 - 2014An investigator-initiated trial sponsored by Abbott Vascular Inc.APPOSEApposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus from Cobalt versus Platinum Alloy Platforms (APPOSE Trial)Prof Darren WaltersClosed
2008 - 2013Bristol Myers SquibbARISTOTLEEC 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 WaltersArchivedSingle Site submission
2008 - 2012Janssen-CilagATLAS 2EC 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 WaltersArchivedSingle Site submission
MedtronicATTAIN PERFORMAAttain Performa™ Quadripolar Lead StudyDr Russell DenmanArchived
2008 - 2013Biosensors Interventional TechnologiesBEACON IIB.E.A.C.O.N. II : A Multi-Centre Registry of BioMatrix drug-eluting stent in Asia-Pacific Countries.Prof Darren WaltersClosedSingle Site submission
2011 - 2013BioTronikBIOLUXTreatment of Bifurcation Lesions with the BIOTRONIK Pantera Lux Drug Eluting Balloon (BIOLUX I)Prof Darren WaltersArchivedSingle Site submission
2013 - presentInvestigator InitiatedCAAN-AFCardiac Resynchronisation Therapy (CRT) And AV Node ablation trial in AFDr Haris HaqqaniRecruitingSingle Site submission
2017 - presentACORCardiac Devices RegistryAustraliasian Cradiac Outcomes Registry - Cardiac Devices RegistryProf Darren WaltersAwaiting RGO approval
2017 - presentACORCardiac Procedures RegistryAustraliasian Cradiac Outcomes Registry - Cardiac Procedures RegistryProf Darren WaltersAwaiting RGO approval
2016 - PresentSt Jude MedicalCardioMEMSCardioMEMSTM HF System Post-Approval StudyDr Scott McKenzieRecruitingSingle Site submission
2008 - 2013CardiomindCARE IIA 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 ArteriesProf Darren WaltersArchvedSingle Site submission
2008 - 2011Merck Sharpe & DohmeCARSClopidogrel and Aspirin Resistance StudyProf Darren WaltersArchivedSingle Site submission
2015 - PresentEdwards LifesciencesCENTERASafety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart ValveProf Darren WaltersFollow UpMulticentre - Lead site
2008 - 2012The Medicines Co.CHAMPION A Clinical Trial Comparing Cangrelor To Clopidogrel In Subjects Who Require Percutaneous Coronary InterventionArchivedSingle Site submission
2017 - PresentEdwards LifesciencesCLASPEdwards PASCAL TrAnScatheter Mitral Valve RePair System Study Prof Darren WaltersRecruitingMulticentre - Lead site
2011 - 2014Coherex WavecrestCoherex LAAA Multi-centre study to evaluate the safety and efficacy of the Coherex Left Atrial Appendage Occlusion SystemProf Darren WaltersArchivedSingle Site submission
Westmead Millenium InstituteCOMFORTConcept of Optimal Management of Ventricular Fibrillation or Very Fast Ventricular TachycardiaDr Russell DenmanArchivedSingle Site submission
2009 - 2016Investigator Initiated RegistryConcordanceHREC/10/QPCH/84: Cooperative National Registry of Acute Coronary Care Guideline Adherence and Clinical EventsProf Darren WaltersClosedMuticentre - Submission
2008 - PresentMedtronicCOREVALVEEC 2801: An Investigator Initiated Clinical Trial using Percutaneous Aortic Valve Replacement (PAVR) with the CoreValve ReValving™ System and CoreValve International ReValving™ Registry:Prof Darren WaltersClosedSingle Site submission
2013 - 2015Authorised PrescriberCOREVALVE APThe 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 - 2011Datascope Corp.CRISP AMIStudy of Mechanical Left Ventricular Unloading with Counterpulsation to reduce Infarct Size Pre-PCI for Acute MIProf Darren WaltersArchivedSingle Site submission
2016 - PresentMedpaceDal-GenEA 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 RaffelRecruiting
2008 - 2011ParmaNeticDANUBEA 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 InterventionProf Darren WaltersArchivedSingle Site submission
2008 - 2011Johnson & JohnsonE Cypher SelectA Multi centre post market surveillanceProf Darren WaltersArchivedSingle Site submission
2012 - 2015 Authorised PrescriberEdwards APThe 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 - 2011MedtronicENDEAVOURA 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 ARTERIESProf Darren WaltersArchivedSingle Site submission
2013 - 2015St Jude MedicalENHANCEEfficacy 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 FractionDr Haris HaqqaniClosedMulticentre - Lead site
2012 - PresentSt Jude MedicalEnligHTN IIIntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN Prof Darren WaltersFollow UpMulticentre - Lead site
2010 - 2016Boston ScientificEVOLVEA 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 LesionProf Darren WaltersClosedSingle Site submission
2012 - PresentBoston ScientificEVOLVE IIA 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 WaltersFollow Up
2014 - 2015Boston ScientificEVOLVE II QCAA 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 WaltersArchivedLead site
2015 - PresentReva Medical IncFANTOM IISafety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary ScaffoldProf Darren WaltersFollow Up
2016 - PresentBoston ScientificFASTFAST Feasibility Study: Fully Absorbable Scaffold Feasibility StudyProf Darren WaltersFollow Up
2014 - PresentImperial College LondonFLAIRProspective, 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 FFRProf Darren WaltersFollow Up
2010 - 2012National Heart, Lung & Blood Institute (NHLBI)FREEDOMEC 2626: Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel diseaseDr Nick BettClosedSingle Site submission
2013 - PresentBayer HealthcareGADACAD2Multicenter 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 analysisDr Christian Hamilton-Craig ClosedSingle Site submission
2017 - AMGENGALACTICA 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 FractionDr Scott McKenzieRecruiting
2015 - 2016Janssen-CilagGEMINIA 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 SyndromeProf Darren WaltersClosed
2013 - 2015AMGENGLAGOVA 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 CatheterizationProf Darren WaltersClosed
2015 - PresentAMGENGLAGOV OPEN LABEL EXTENSIONA Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab Prof Darren WaltersFollow Up
2013 - PresentGlobal GenomicsGLOBALGenetic Loci and the Burden of Atherosclerotic Lesions.Dr Christian Hamilton-Craig On hold
2014 - PresentECRI/CardiolysisGLOBAL LEADERSCOMPARATIVE 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 RaffelFollow Up
2013 - 2014St Jude MedicalILUMIEN IObservational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage IDr Chris RaffelArchivedSingle Site submission
2012 - PresentBoston ScientificINGEVITYActive Fixation and Passive Fixation Pace/ Sense Lead Clinical StudyDr Russell DenmanFollow UpSingle Site submission
2004Investigator Initiated TrialInvestigation of HITTSProspective Screening for Heparin-induced Thrombocytopenia in Cardiac Transplant Patients: Incidence, Outcomes and RecommendationsProf Darren WaltersArchivedSingle Site submission
2008 - 2011EisaiLANCELOTA 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 syndromeDr Nick BettArchivedSingle Site submission
2014 - PresentGlaxoSmithKlineLATITUDEPhase III trial comparing losmapimod vs placebo x 12 weeks on the incidence of MACE in subjects with ACS (NSTEMI and STEMI)Dr Chris RaffelArchived
2013 - 2016Biosensors EuropeLEADERS FREEA PROSPECTIVE RANDOMIZED COMPARISON OF THE BIOFREEDOMTM BIOLIMUS A9TM DRUG COATED STENT VERSUS THE GAZELLE™ BARE METAL STENT IN PATIENTS AT HIGH RISK FOR BLEEDINGProf Darren WaltersClosedSingle Site submission
2015 - PresentSt Jude MedicalLEADLESS IIA Safety and effectiveness trial for a leadless pacemaker systemDr Russell DenmanFollow Up
2014 - PresentInvestigator Initiated RegistryMARS REGISTRYThis is an Asia-Pacific multi-centre international observational registry of patients with mitral regurgitation treated with the MitraClipProf Darren WaltersOngoingSingle Site submission
2012 - 2014Abbott VascularMitra ClipMitraClip System ANZ Clinical Trial. A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand.Prof Darren WaltersClosed outSingle Site submission
2014 - PresentInvestigator Initiated TrialMITRA CLIP MRI ECHOQuantitative Assessment of Post-implant Function by MRI and EchoDr Christian Hamilton-Craig On holdSingle Site submission
2013 - 2014ServierMODIFYEffects 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 RaffelArchived
2010 - 2011Investigator Initiated Registry/
Monash
MOODCAREAn implementation trial of a telephone-based care management program targeting depression for patients following myocardial infarctionProf Darren WaltersArchivedSingle Site submission
2016 - PresentArmaron BioNP202 for Treatment after a Heart AttackA 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 WaltersRecruiting
2008 - 2011New York UniversityOAT TrialOccluded Artery TrialProf Darren WaltersAchived
2011 - 2014Investigator Initiated TrialOCT RegistryMGH Optical Coherence Tomography RegistryDr Chris RaffelClosedSingle Site submission
2010 - 2014Investigator Initiated TrialOCT v FFRValidation of Intravascular Optical Coherence Tomography Parameters With Fractional Flow Reserve for Assessment of Coronary Stenosis SeverityDr Chris RaffelClosedSingle Site submission
2014 - PresentSanofi AventisODYSSEYA 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 SyndromeDr Chris RaffelFollow Up
2012 - 20013Investigator initiated trial supported by Biosensors International, SingaporeOPTIMAOPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF INTIMAL TISSUE AND MALAPPOSITIONProf Darren WaltersArchivedSingle Site submission
2013 - PresentAuthorised PrescriberPantera LuxCoronary 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 - PresentNovartisPARADISE MIA 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 infarctionDr Scott McKenzieRecruiting
2017 - PresentEdwards LifesciencesPARTNER 3A 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 ReplacementProf Darren WaltersRecruitingMulticentre - Lead site
2014 - PresentJanssen-CilagPIONEERAn 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 InterventionProf Darren WaltersClosed
2009 - 2013Boston ScientificPLATINUM QCAA prospective Multi-Centre Trial to assess an Everolimus – Eluting Coronary Stent System (PROMUS Element)Prof Darren WaltersAchivedSingle Site submission
2012 - 2013Boston ScientificPLATINUM WORKHORSEA 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 LesionsProf Darren WaltersArchivedSingle Site submission
2013 - PresentSt Jude MedicalPORTICO IInternational long-term follow-up study of patients implanted with a PORTICO™ valveProf Darren WaltersRecruiting
2016 - PresentSt Jude MedicalPORTICO IDEPorticoTM Re-sheathable transcatheter Aortic Valve System US IDE Trial Prof Darren WaltersRecruiting
2008 - 2011St Jude MedicalPRECISE RegistryPFO closure and cryptogenic stroke registryProf Darren WaltersArchivedSingle Site submission
2012 - PresentGeorge InstitutePROTECT ICDProgrammed Ventricular Stimulation to Risk Stratify for Early Cardioverter-defibrillator Implantation to Prevent Tachyarrhythmia following Acute Myocardial InfarctionDr Russell DenmanRecruiting
MedtronicProtect PaceEC2664 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 DenmanClosedSingle Site submission
2008 - 2013MedtronicPROTECT PCIAn 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 WaltersClosedSingle Site submission
2014 - PresentBoehringer IngelheimREDUAL PCIA 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 stentingProf Darren WaltersFollow Up
2017 - PresentCardiac DimensionsREDUCE FMR The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System? in Reducing Functional Mitral Regurgitation (FMR) Associated with Heart FailureProf Darren WaltersRecruiting
2014 - PresentCorviva/
DC Devices
REDUCE LAP-HFA study to evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart FailureDr Scott McKenzieFollow Up
2017 - PresentCorvia REDUCE LAP-HF REF RCTReduce 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 FailureDr Scott McKenzieRecruiting
2012 - 2015Boston Scientific/VessixREDUCE-HTNTReatment of rEsistant hypertension using a raDiofrequency percUtaneous transluminal angioplasty CathetErProf Darren WaltersClosed
2012 - PresentBoston ScientificREPRISE IIREpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Evaluation of Safety and PerformanceProf Darren WaltersFollow UpSingle Site submission
2015 - PresentBoston ScientificREPRISE IIIREpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical EvaluationProf Darren WaltersRecruitingSingle Site submission
2014 - PresentBoston Scientific REPRISE NG DSREpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LotuS™ ValvE with the Next Generation Delivery SystemProf Darren WaltersFollow UpSingle Site submission
2008 - 2012MedtronicRESOLUTEThe 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 WaltersArchivedSingle Site submission
2014 - PresentReva Medical IncRESTORE IIReZolve2™ Sirolimus-Eluting Bioresorbable Coronary ScaffoldProf Darren WaltersClosedSingle Site submission
2013 - 2015MedtronicREVEAL LINQThe 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 deviceDr Russell DenmanArchivedSingle Site submission
2015 - PresentMedtronicREVELUTIONA Clinical Evaluation of the Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (Polymer-free DES TrialProf Darren WaltersFollow Up
2008 - 2011Janssen-CilagROCKETA 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 WaltersArchivedSingle Site submission
2009 - 2012AstraZenecaSATURNStudy 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 diseaseProf Darren WaltersArchivedSingle Site submission
Biosense WebsterSMARTTOUCHTHERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial FibrillationDr Haris HaqqaniArchivedMulticentre - Lead site
2010 - PresentEdwards LifesciencesSOLACE-AUA 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 WaltersFollow UpMulticentre - Lead site
2017 - PresentUniversity of AlbertaSodium HFThe long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failureHaunnah RheaultRecruiting
2009 - 2012GlaxoSmithKlineSOLSTICEHREC/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 WaltersArchivedSingle Site submission
2010 - 2012Edwards LifesciencesSOURCE ANZEdwards SAPIEN™ Transcatheter Heart Valve Source ANZ Transpical Ascendra Introducer SystemProf Darren WaltersArchivedSingle Site submission
2009 - 2013Abbott VascularSPIRIT PRIMEA Clinical Evaluation of the XIENCE PRIME™ and XIENCE PRIME ™ LL Everolimus Eluting Coronary Stent SystemProf Darren WaltersArchivedSingle Site submission
2015 - PresentTendyneTENDYNE Expanded Clinical Study of the Tendyne Mitral Valve SystemProf Darren WaltersRecruiting
2013 - PresentGeorge InstituteTEXTMEDSText Messages to improve medication adherence and secondary preventionDr Christian Hamilton-Craig Follow Up
2008 - 2012Schering PloughTRACEREC 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 BettArchivedSingle Site submission
2017 - present4TECGTRICINCHFeasibility Study of the Percutaneous 4Tech Tricinch Coil Tricuspid Repair SystemDr. Darren WaltersRecruiting
2011 - 2012Eli LillyTRIPLET (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 InterventionProf Darren WaltersArchivedSingle Site submission
2016 - PresentMerck Sharpe & DohmeVICTORIAVerICiguaT glObal study in subjects with heart failure with Reduced ejectIon frAction (VICTORIA)Dr Scott McKenzieRecruiting
2008 - 2012Abbott VascularZOMAXXA 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 LesionsProf Darren WaltersArchivedSingle Site submission
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