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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de CAEN
  Caen, France Recruiting

Study contacts

• Principal investigator: Corentin CHAUMONT, MD — University Hospital, Rouen
• Study coordinator: Corentin CHAUMONT, MD
• Email: corentin.chaumont@chu-rouen.fr
• Phone: 232888116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.