Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06299514

RAFT - Pace &Ablate

Led by Habib Khan · Updated on 2026-02-02

600

Participants Needed

12

Research Sites

296 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

RAFT - Pace &Ablate

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with permanent or persistent atrial fibrillation
  • Patients with NYHA Class II to IVa heart failure symptoms
  • On guideline-driven medical therapy for heart failure for at least 3 months with NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if hospitalized for heart failure within the past year
Not Eligible

You will not qualify if you...

  • Hospitalized patients needing intensive care or intravenous inotropic agents within the last 4 days
  • Life expectancy less than or equal to 1 year 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 therapy
  • Known history of WHO Class I pulmonary hypertension or related conditions
  • Participation in other clinical trials affecting this study's objectives
  • Existing cardiac resynchronization therapy or biventricular pacemaker
  • Pregnancy
  • Guideline indication for cardiac resynchronization therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

H

Habib R Khan, MBBS, PhD

CONTACT

A

Abbie Pardo

CONTACT

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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RAFT - Pace &Ablate | DecenTrialz