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NCT Number: NCT06299514

RAFT - Pace &Ablate

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmia Atrial Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pacemaker Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Pace and Ablate

Device

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

Other names: P&A, pacemaker and atrioventricular node ablation

medication

Drug

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

Other names: Optimal heart failure therapy

Primary outcomes

  1. Winratio

    Time frame: 12 months

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

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

    Mortality from any cause within the 12 month of follow up period

  2. Cardiovascular mortality

    Time frame: 12 months

    Mortality attributed to cardiovascular causes within 12 month follow up period

  3. Number of heart failure events

    Time frame: 12 months

    Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay

  4. All-cause hospitalization

    Time frame: 12 months

    ER admission or overnight stay

  5. Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)

    Time frame: 6 months

    Change in Kansas HF score from baseline. KCCQ is a 23-item self-administered questionnaire that measures the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life (QoL). KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.

  6. Exercise

    Time frame: 6 months

    Change in 6 minute walk distance from baseline

  7. Biochemical marker

    Time frame: 6 months

    Change in NTproBNP from baseline

  8. Cognitive assessment

    Time frame: 12 months

    Change in cognitive assessment scores from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Habib R Khan, MBBS, PhD

CONTACT

[email protected]

519-6633746

Kelli Tyndall

CONTACT

[email protected]

519-685-8500 ext. 37232

Sponsors and collaborators

Lead sponsor

Habib Khan

Other

Registry information

Official study title

Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing

Acronym: RAFT-P&A RCT

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Mar 8, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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