Actively Recruiting
Resynchronization for Ambulatory Heart Failure Trial Comparing Pharmacological Rate Control Versus Pace and Ablate With Conduction System Pacing in Chronic Atrial Fibrillation
Led by Habib Khan · Updated on 2026-05-26
600
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms such as skipped beats, shortness of breath, stroke, or fluid buildup in the lungs or legs. This research aims to compare a new pacing method called Conduction System Pacing (CSP) combined with atrioventricular (AV) node ablation against optimal medical therapy for treating AF, especially in patients who have difficulty tolerating medications. The study focuses on patients with heart failure symptoms and permanent or persistent AF. Participants will be randomly assigned to one of two groups. One group will receive usual medical care with medications to control heart rate and manage heart failure, including implantable cardioverter defibrillators (ICD) if their heart function is reduced. The other group will receive CSP with an ICD if needed, followed by catheter-based AV node ablation within four weeks to regulate heart rhythm by pacing the heart directly. During the study, participants will be monitored for up to 12 months with evaluations including heart failure events, mortality, hospitalizations, quality of life, exercise capacity, biochemical markers, and cognitive assessments. Researchers will use a measure called Winratio at 12 months to compare outcomes. The study includes a single-blind design and will collect data on how well the treatments control heart rhythm and impact overall health.
CONDITIONS
Brief Title
RAFT - Pace &Ablate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with permanent or persistent atrial fibrillation
- Patients with heart failure symptoms classified as NYHA Class II to IVa
- Receiving guideline-driven medical therapy for heart failure for at least 3 months
- NT-proBNP level ≥ 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 in the last 4 days
- Life expectancy of 1 year or less 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
- History of WHO Class I pulmonary hypertension or related conditions
- Participation in competing clinical trials affecting this study
- Existing cardiac resynchronization therapy or biventricular pacemaker
- Pregnant patients
- Guideline indication for cardiac resynchronization therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either pharmacological rate control with optimized heart failure medications or conduction system pacing followed by atrioventricular node ablation. Implantable cardioverter-defibrillator (ICD) placement occurs if left ventricular ejection fraction is 35% or less.
1 to 2 visits within the first month depending on treatment assignment, followed by regular follow-up visits
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
K
Kelli Tyndall
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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