Clinical Trials

The purpose of this study is to compare the rate of arrhythmia-induced events between paediatric Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) patients with and without implantable cardioverter defibrillator (ICDs), and to determine the quality of life and psychosocial functioning of paediatric CPVT patients with and without ICDs.

The purpose of this study is to demonstrate safety and effectiveness of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

The purpose of this study is to determine if defibrillation threshold testing (DFT) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT). This will be done by comparing pre-and-post DFT hs-cTnT levels in these patients.

The TRACER-ICD Study will be a 60 month study (9 months preparation, 45 months to conduct the study, 6 months data analysis and manuscript preparation) in which a prospective cohort of 500 patients receiving ICDs as part of clinical care at 5 sites will be followed for up to 18 months or death, with data collected from patient or proxy interviews (baseline, in-person; quarterly, by telephone) and electronic record reviews (baseline and quarterly), including remote monitoring data. Data collected through these complementary methods will be used to describe the following aspects of patients’ clinical course:

• focused geriatric assessment ...

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.

This study is designed to identify genes shared between humans with hypertrophic cardiomyopathy and rhesus macaque primates who have experienced sudden cardiac death.

The purpose of the MODULAR ATP Clinical Study is to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical embolic events from device lead thrombus. The investigators are conducting this study to determine if the anticoagulant medication Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.

The purpose of this study is to compare the safety and effectiveness of Edoxaban to Warfarin when used in patients with a non-valve related atrial fibrillation undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.

The purpose of this study is to collect electrogram data from an investigational lead placed in an extravascular space, for the development of a future Implantable Cardioverter Defibrillator (ICD) system.

The aim of this study is to identify genes shared between humans and rhesus macaque primates who have been diagnosed with hypertrophic cardiomyopathy and have died suddenly.

The purpose of this study is to gather information to develop and validate a predictive tool for predicting the response to CRT therapy.

The purpose of this study is to evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.

The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following  generator replacement, upgrade, revision, or new CRT-D implant.

Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack ...

The aim of this study is to evaluate the relation of the acute pacing threshold (volts at ‘x’ pulse width) to the chronic pacing threshold of a pacemaker/ICD lead by studying the threshold during implantation at different pulse widths (eg. Twice of ‘x’, Three times of ‘x’).