RecruitingNot ApplicableNCT06299514

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


Sponsor

Habib Khan

Enrollment

600 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The RAFT Pace & Ablate study tests whether a combination of AV node ablation (a procedure that interrupts faulty electrical signals in the heart) plus a permanent pacemaker implant improves heart failure symptoms better than standard medical treatment alone in people with both permanent atrial fibrillation (an irregular heart rhythm) and heart failure. **You may be eligible if...** - You have permanent or persistent atrial fibrillation (AF) — meaning your heart is always in an irregular rhythm - You have heart failure symptoms (NYHA class II–IVa) - You have been on appropriate heart failure medications for at least 3 months - Your heart failure blood marker (NT-proBNP) is elevated at a qualifying level **You may NOT be eligible if...** - You are currently in intensive care or on IV heart medications - Your life expectancy is less than 1 year from a non-heart cause, or you are awaiting a heart transplant - You had a recent heart attack (within 4 weeks) or heart procedure (within 3 months) - You have severe untreated heart valve disease or an artificial tricuspid valve - You have pulmonary hypertension, restrictive or hypertrophic cardiomyopathy, or severe lung disease - You already have a CRT (cardiac resynchronization therapy) device or have a standard indication for one - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPace and Ablate

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

DRUGMedication

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


Locations(12)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Waterloo Wellington Cardiovascular Research Institute

Kitchener, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Ottawa Heart Institute Research Corporation

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre Hospitalier de L'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

Hôpital Fleurimont

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06299514


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