RAFT - Pace &Ablate

NCT06299514 | Recruiting DMC

• 1 other identifier: 4754
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Winratio

  Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.

  12 months

Secondary Outcomes (8)

• All-cause mortality

  12 months

• Cardiovascular mortality

  12 months

• Number of heart failure events

  12 months

• All-cause hospitalization

  12 months

• Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)

  6 months

Study Arms (2)

Pharmacological Therapy

ACTIVE COMPARATOR

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%

Drug: Medication

P&A-CSP

EXPERIMENTAL

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.

Device: Pace and Ablate

Interventions

Pace and Ablate DEVICE

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

Also known as: P&A, pacemaker and atrioventricular node ablation

P&A-CSP

Medication DRUG

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

Also known as: Optimal heart failure therapy

Pharmacological Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with permanent AF/persistent AF (in AF)
• Patients with NYHA Class II -IVa HF symptoms
• 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

You may not qualify if:

• In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
• 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
• Unable or unwilling to provide informed consent
• Uncorrected primary valvular disease or prosthetic tricuspid valve
• Restrictive, hypertrophic, or irreversible form of cardiomyopathy
• 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
• 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

Sponsors & Collaborators

• Habib Khan: lead

Study Sites (12)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

NOT YET RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, B3S0H6, Canada

RECRUITING

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L2X2, Canada

RECRUITING

Waterloo Wellington Cardiovascular Research Institute

Kitchener, Ontario, N2G1G3, Canada

RECRUITING

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

RECRUITING

Southlake Regional Health Centre

Newmarket, Ontario, Canada

RECRUITING

Ottawa Heart Institute Research Corporation

Ottawa, Ontario, K1Y4W7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

NOT YET RECRUITING

Centre Hospitalier de L'Université de Montréal (CHUM)

Montreal, Quebec, H2X0A9, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

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

Québec, Quebec, G1V4G5, Canada

RECRUITING

Hôpital Fleurimont

Sherbrooke, Quebec, J1H5N4, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Habib R Khan, MBBS, PhD

CONTACT

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

Kelli Tyndall

CONTACT

5196858500; Kelli.Tyndall@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-01

Locations

CA (12)