Actively Recruiting
RAFT - Pace &Ablate
Led by Habib Khan · Updated on 2026-02-02
600
Participants Needed
12
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RAFT - Pace &Ablate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with permanent or persistent atrial fibrillation
- Patients with NYHA Class II to IVa heart failure symptoms
- On guideline-driven medical therapy for heart failure for at least 3 months with NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if hospitalized for heart failure within the past year
You will not qualify if you...
- Hospitalized patients needing intensive care or intravenous inotropic agents within the last 4 days
- Life expectancy less than or equal to 1 year from non-cardiac causes or anticipating transplant within 1 year
- Acute coronary syndrome within 4 weeks or coronary revascularization within 3 months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible cardiomyopathy
- Severe pulmonary diseases requiring oxygen therapy
- Known history of WHO Class I pulmonary hypertension or related conditions
- Participation in other clinical trials affecting this study's objectives
- Existing cardiac resynchronization therapy or biventricular pacemaker
- Pregnancy
- Guideline indication for cardiac resynchronization therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
Not Yet Recruiting
2
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3S0H6
Actively Recruiting
3
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L2X2
Actively Recruiting
4
Waterloo Wellington Cardiovascular Research Institute
Kitchener, Ontario, Canada, N2G1G3
Actively Recruiting
5
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A5A5
Actively Recruiting
6
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Actively Recruiting
7
Ottawa Heart Institute Research Corporation
Ottawa, Ontario, Canada, K1Y4W7
Actively Recruiting
8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Not Yet Recruiting
9
Centre Hospitalier de L'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X0A9
Actively Recruiting
10
Montreal Heart Institute
Montreal, Quebec, Canada
Actively Recruiting
11
Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval)
Québec, Quebec, Canada, G1V4G5
Actively Recruiting
12
Hôpital Fleurimont
Sherbrooke, Quebec, Canada, J1H5N4
Actively Recruiting
Research Team
H
Habib R Khan, MBBS, PhD
CONTACT
A
Abbie Pardo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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