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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation Rapid
• Interventions: Procedure: left bundle branch of His pacing; Procedure: right ventricular pacing

• Registration Number: NCT06061978
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-29
• Study Start: 2023-11-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2027-05-27
• Study Completion: 2027-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)	right ventricular pacing	-
left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)	right ventricular pacing	-
left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)	left bundle branch of His pacing	-
right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)	left bundle branch of His pacing	-

Primary Outcome Measures

Name	Time	Method
Maximum Oxygen Consumption (VO2 max) in mL/min/kg.	18 months

Secondary Outcome Measures

Name	Time	Method
Determination of NT pro BNP or BNP	18 months
walking test distance covered	18 months
echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time)	18 months
Physical component of quality-of-life scale (SF-36)	18 months
Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP	18 months

Trial Locations

Locations (1)

CHU de CAEN; 🇫🇷 Caen, France