NCT06299514Recruiting
RAFT - Pace &Ablate
Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 25 Apr 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Habib Khan
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06299514
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 25 Apr 2024 to the primary completion date, 31 Dec 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Severe pulmonary diseases requiring oxygenation
- Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension
- Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)
Other
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Unable or unwilling to provide informed consent
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
- Patients enrolled in competitive clinical trials that will affect the objectives of this study
- Existing CRT/BiVP
- Patients who are pregnant
- Guideline indication for CRT
- More than 20% pacing with an existing pacemaker
Who the study is looking for
- Patients with permanent AF/persistent AF (in AF)
- Patients with NYHA Class II -IVa HF symptoms
- Guideline driven medical therapy (GDMT) for HF for at least 3 months:
- for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L
- for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Hamilton Health Sciences Corporation Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Waterloo Wellington Cardiovascular Research Institute Coordinator of this site? Confirm its status | Kitchener | Canada | Recruiting |
| London Health Sciences Centre, University Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Southlake Regional Health Centre Coordinator of this site? Confirm its status | Newmarket | Canada | Recruiting |
| Ottawa Heart Institute Research Corporation Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval) Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Hôpital Fleurimont Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Victoria Cardiac Arrhythmia Trials Coordinator of this site? Confirm its status | Victoria | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.