RAFT - Pace &Ablate

Last updated: February 27, 2025
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Heart Failure

Chest Pain

Treatment

Pace and Ablate

Medication

Clinical Study ID

NCT06299514
4754
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. In hospital patients needing intensive care or intravenous inotropic agent in thelast 4 days

  2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating atransplant 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) whichincludes PH associated with CVD, collagen vascular disease, congenital shunts,cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis ordrug-associated PH as well as those with high suspicion of irreversible pulmonaryhypertension

  9. Patients enrolled in competitive clinical trials that will affect the objectives ofthis study

  10. Existing CRT/BiVP

  11. Patients who are pregnant or intend to become pregnant

  12. Guideline indication for CRT

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Pace and Ablate
Phase:
Study Start date:
April 25, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • London Health Sciences Centre - University Hospital

    London, Ontario N6A5A5
    Canada

    Active - Recruiting

  • London Health Sciences Research

    London, Ontario N6G5A5
    Canada

    Site Not Available

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