Recruiting

RAFT-P&A

Sponsor:

Habib Khan

Code:

NCT06299514

Conditions

Atrial Fibrillation

Heart Failure

Pacemaker

Arrhythmia Atrial

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pace and Ablate

Medication

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Heart Failure

Pacemaker

Arrhythmia Atrial

Study ID

NCT06299514

Start date

Apr 25, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (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

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
13. More than 20% pacing with an existing pacemaker
14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pharmacological Therapy

Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%

experimental: P&A-CSP

Patients randomized to P\&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.

Interventions

Pace and Ablate

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

Medication

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

Primary outcome measure

  • Winratio [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Habib R Khan, MBBS, PhD

519-6633746habib.khan@lhsc.on.ca

Kelli Tyndall

519-685-8500Kelli.Tyndall@lhsc.on.ca

Locations

Victoria Cardiac Arrhythmia Trials

Recruiting

Victoria, British Columbia, Canada

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3S0H6

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada, L8L2X2

Waterloo Wellington Cardiovascular Research Institute

Recruiting

Kitchener, Ontario, Canada, N2G1G3

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Dr. Habib Khan

519-663-3746habib.khan@lhsc.on.ca

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada

Ottawa Heart Institute Research Corporation

Recruiting

Ottawa, Ontario, Canada, K1Y4W7

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Centre Hospitalier de L'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X0A9

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada

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

Recruiting

Québec, Quebec, Canada, G1V4G5

Hôpital Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

More Information

Sponsor

Habib Khan

Last update posted

Jul 1, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Habib Khan on 2026-07-01.