ARRHYTHMIA STUDIES:Contracted Research, Clinical Trials, Studies awaiting ethics/other approval /contracts (starting soon)
Coordinating center: PHRI (McMaster University)
Local PI: C Khoo
Co-investigators: A Khadem, A Tischenko, K Wolfe, C Khoo
Objective: Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-clinical Atrial Fibrillation - prospective, randomized , parallel group, double-blinded trial to determine if the use of Apixaban in patients with device-related sub-clinical atrial fibrillation (SCAF) will reduce the incidence of stroke and systemic embolism compared to aspirin.
- Permanent pacemaker or defibrillator (with or without resynchronization)
or insertable cardiac monitor capable of detecting SCAF.
- At least one episode of device detected SCAF?6 minutes in duration (atrial rate > 175 per minute if an atrial lead is present), but no single episode > 24 hours in duration at any time prior to enrollment. SCAF requires electrogram confirmation (at least one episode) unless >/= 6 hours in duration.
- Age >/= 18 year
- CHA2DS2 -VASc score of >/= 4
Coordinating center: Montreal Heart Institute
Local PI: C Khoo
Co-investigators: A Khadem, A Tischenko, K Wolfe, C Seifer
Objective: The primary objective of the study is to determine whether a low dose of Rivaroxaban (15 mg) in patients with non-valvular AF and a low risk of stroke reduce the combined endpoints consisting of stroke, TIA, or neurocognitive decline.
- Age at consent >/= 30 to </= 60 years;
- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing (routine 12 lead electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker [PM] or implantable cardiac defibrillator [ICD] interrogation of at least 30 seconds) within the prior 12 months
- Low risk of stroke as defined by the absence of all of the following:
- Prior stroke or TIA,
- Diabetes mellitus,
- Congestive heart failure (New York Heart Association class II or higher at the time of enrollment or a left ventricular ejection fraction <35%);
- Signed written informed consent.