Comparing left and right heart pacing after atrioventricular node ablation for atrial fibrillation

Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

This study is testing whether pacing the heart from the left side works better than the traditional right side for people who have had a procedure to treat rapid atrial fibrillation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Caen)
• Trial ID: NCT06061978 on ClinicalTrials.gov

What this trial studies

This study evaluates the functional benefits of pacing from the left bundle branch of His compared to traditional right ventricular pacing in patients who have undergone atrioventricular node ablation for rapid atrial fibrillation. Participants will have a pacemaker implanted with leads in both locations, and the study aims to determine which pacing method provides better outcomes. The study will include patients who have had the ablation procedure within the last 15 days and meet specific inclusion criteria. The goal is to assess the effectiveness of these pacing strategies in improving heart function and patient quality of life.

Who should consider this trial

Good fit: Ideal candidates are patients with a pacemaker implanted who have recently undergone atrioventricular node ablation for rapid atrial fibrillation.

Not a fit: Patients with significant heart function impairment (LVEF < 40%) or those unable to perform a maximal cardiorespiratory effort test may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with rapid atrial fibrillation.

How similar studies have performed: While the specific approach of left bundle branch pacing is relatively novel, similar studies have shown promising results in improving outcomes for patients with pacing needs.

Eligibility criteria

Inclusion Criteria:

1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).

5\) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form

Exclusion Criteria:

1. Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale \< 5).
2. LVEF \< 40% at inclusion
3. Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
4. Patient participating in another interventional trial
5. Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
6. Pregnant, parturient or breast-feeding women, or those without proven contraception

Where this trial is running

Caen

• CHU de CAEN — Caen, France (Recruiting)

Study contacts

• Principal investigator: Corentin CHAUMONT, MD — University Hospital, Rouen
• Study coordinator: Corentin CHAUMONT, MD

Conditions Atrial Fibrillation Rapid