Clinical trial NCT06061978: Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
Official title: Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Rapid
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
timeFrame: 18 months
Secondary outcomes:
measure: walking test distance covered
timeFrame: 18 months
measure: 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)
timeFrame: 18 months
measure: Determination of NT pro BNP or BNP
timeFrame: 18 months
measure: Physical component of quality-of-life scale (SF-36)
timeFrame: 18 months
measure: Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP
timeFrame: 18 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de CAEN
Study officials:
affiliation: University Hospital, Rouen
name: Corentin CHAUMONT, MD
role: PRINCIPAL_INVESTIGATOR
References: