Controlling heart rate in patients with atrial fibrillation using a pacemaker and ablation

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

This study tests a new way to help people with atrial fibrillation and heart failure by using a pacemaker and a procedure to control their heart rate better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 12 sites (Victoria, British Columbia and 11 other locations)
• Trial ID: NCT06299514 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate a novel approach for managing atrial fibrillation (AF) in patients who have heart failure symptoms. The method involves implanting a pacemaker and performing ablation on the atrioventricular (AV) node to regulate heart rhythm effectively. By intentionally damaging the AV node, the trial seeks to prevent AF from affecting the heart's ventricles, allowing the pacemaker to maintain a stable heart rate. This approach is particularly targeted at patients who struggle with medication side effects or ineffective treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with permanent or persistent atrial fibrillation and New York Heart Association (NYHA) Class II-IV heart failure symptoms.

Not a fit: Patients with a life expectancy of less than one year from non-cardiac causes or those requiring intensive care are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a permanent solution for patients with atrial fibrillation and heart failure, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using similar approaches for managing atrial fibrillation, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Patients with permanent AF/persistent AF (in AF)
2. Patients with NYHA Class II -IVa HF symptoms
3. Guideline driven medical therapy for HF for at least 3- months with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year

Exclusion Criteria:

1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
3. Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
4. Unable or unwilling to provide informed consent
5. Uncorrected primary valvular disease or prosthetic tricuspid valve
6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy
7. Severe pulmonary diseases requiring oxygenation
8. 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
9. Patients enrolled in competitive clinical trials that will affect the objectives of this study
10. Existing CRT/BiVP
11. Patients who are pregnant
12. Guideline indication for CRT

Where this trial is running

Victoria, British Columbia and 11 other locations

• Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada (Not_yet_recruiting)
• Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Recruiting)
• Waterloo Wellington Cardiovascular Research Institute — Kitchener, Ontario, Canada (Recruiting)
• London Health Sciences Centre - University Hospital — London, Ontario, Canada (Recruiting)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada (Recruiting)
• Ottawa Heart Institute Research Corporation — Ottawa, Ontario, Canada (Recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
• Centre Hospitalier de L'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval) — Québec, Quebec, Canada (Recruiting)
• Hôpital Fleurimont — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Habib R Khan, MBBS, PhD

Conditions Atrial Fibrillation; Heart Failure; Pacemaker; Arrhythmia Atrial