Cardiology and Cardiac Surgery
ADVISA
Principal Investigator: Dr Neil Strathmore
The Advisa pacemaker platform is the next generation MRI labelled pacemaker system and it has been approved for use in Australia and Europe in a MRI environment. Although the Advisa MRI system has been approved for use in Australia and Europe additional safety and effectiveness data is required for submission to the FDA in the United States for device approval. The study is a prospective, randomized controlled, non-blinded multi-centre study. Long-term device effects will not be assessed in this study. 270 subjects will be enrolled into the study globally. 180 subjects will be randomized into the experimental (subjects completing an MRI scan) group, and 90 subjects will be randomized into the control (subjects not completing an MRI scan) group. A series of MR scans, including scans of the chest region, will be obtained for all subjects randomized to the MRI group.
The primary objectives of the study will compare adverse events and data from the pacemakers between the experimental and control groups to determine if the device is safe during an MRI scan of the chest.
Status: Recruiting
Contact: Clinical Trials and Research Centre
APPRAISE-2
A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute coronary Syndrome: Apixaban for Prevention of Acute Ischemic Events - 2 (APPRAISE-2)
Principal Investigator: Dr Ronald Dick
The aim of this study is to determine if Apixaban, a new oral anticoagulant, when given in addition to standard treatment to subjects who have recently experienced unstable angina or a heart attack, is safe and can prevent further cardiovascular events such as another heart attack, unstable angina or stroke. APPRAISE-2 is an international, multi-center, double-blind, placebo-controlled, randomized clinical trial assessing the effect of Apixiban on rates of cardiovascular death, myocardial infarction or ischemic stroke.
Status:
Contact: Clinical Trials and Research Centre
CoreValve
International ReValving® Registry: Percutaneous Aortic Valve Replacement (PAVR) with the CoreValve ReValving System
Principal Investigator: Dr Tony Walton
Aortic valve stenosis occurs in 1-2% of the over 65 population and 4% of the over 85 population and progressive valve narrowing leads to the need for valve replacement that traditionally requires open-heart surgery. CoreValve has developed a device for percutaneous valve replacement that can be performed utilising local anaesthesia. This study evaluates the performance, efficacy and safety of the percutaneous implantation of CoreValve’s prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis who have an elevated surgical risk.
Status: Recruiting
Contact: Clinical Trials and Research Centre
ENGAGE
Endurant Stent Graft Natural Selection Global Post-market Registry a multicentre, post-market, non-interventional, prospective study
Principal Investigator: Professor Michael Grigg
The Endurant Stent Graft System is a new generation percutaneous aortic repair system. ENGAGE is a registry that aims to expand our clinical knowledge by prospectively collecting global ‘real world’ safety and clinical performance data, and increase the clinical evidence about the safety and effectiveness of these devices.
Status:
Contact: Clinical Trials and Research Centre
PEGASUS
A randomised, double-blind, placebo controlled, parallel group, multinational trial, to assess the prevention of thrombotic events with Ticagrelor compared to placebo on a background of ASA therapy in patients with history of myocardial infarction.
Principal Investigator: Dr Ronald Dick
The primary aim of this study is to compare the effect of long term treatment with Ticagrelor vs placebo on a background of acetyl salicylic acid (ASA) on the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke in participants with a history of MI and a high risk for developing atherothrombotic events. 21,000 participants will be enrolled from 1,000 sites worldwide an followed for a minimum of 12 months, and up to 38 months.
Status: Recruiting
Contact: Clinical Trials and Research Centre
ALECARDIO
Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D).
Principal Investigator: Dr Ronald Dick
Patients with Type 2 Diabetes have an increased risk of cardiovascular disease. The aim of this project is to assess whether aleglitazar, a drug to assist in control of blood sugar levels in diabetics, can be used to decrease the death rate or increase the health state of people who have type two diabetes and have recently experienced a heart attack or symptoms of acute coronary syndrome (symptoms resulting from decreased blood flow to the heart).
Status:
Contact: Clinical Trials and Research Centre
Australian Cardiac Procedure Registry - ACPR
Principal Investigator: Dr Ronald Dick
Despite the declining incidence of coronary heart disease (CHD) over the last two decades, CHD remains the single largest cause of death and disability in Australia. The decline in incidence is partially attributable to major therapeutic advances including coronary artery bypass grafting, percutaneous coronary intervention and improved pacing techniques. This study aims to pilot a national registry in interventional cardiology and cardiac surgery to provide information and outcomes of established and emerging procedures performed across Australia.
SPIRIT PRIME
A Clinical Evaluation of the XIENCE PRIME™ and XIENCE PRIME™ LL Everolimus Eluting Coronary Stent System
Principal Investigator: Dr Ronald Dick
The XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System is a device/drug combination product used to improve coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions. This study is a prospective, two-arm, open-labelled, multicentre registry evaluating the safety and effectiveness of this system.