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RECRUITING
NCT06299514
NA

RAFT - Pace &Ablate

Sponsor: Habib Khan

View on ClinicalTrials.gov

Summary

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.

Official title: Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-04-25

Completion Date

2029-12-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DEVICE

Pace and Ablate

Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA)

DRUG

Medication

Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis

Locations (12)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Waterloo Wellington Cardiovascular Research Institute

Kitchener, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Ottawa Heart Institute Research Corporation

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre Hospitalier de L'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval)

Québec, Quebec, Canada

Hôpital Fleurimont

Sherbrooke, Quebec, Canada