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 Overview
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Brief Summary
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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

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

Conditions
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Atrial Fibrillation Rapid

Intervention / Treatment
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* Procedure: left bundle branch of His pacing
* Procedure: right ventricular pacing


Participation Criteria
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Eligibility Criteria
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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: Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale < 5). LVEF < 40% at inclusion Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship. Patient participating in another interventional trial 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. Pregnant, parturient or breast-feeding women, or those without proven contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)<br> | Procedure: left bundle branch of His pacing<br>* left bundle branch of His pacing<br>Procedure: right ventricular pacing<br>* right ventricular pacing<br>|
| Experimental: right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)<br> | Procedure: left bundle branch of His pacing<br>* left bundle branch of His pacing<br>Procedure: right ventricular pacing<br>* right ventricular pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Oxygen Consumption (VO2 max) in mL/min/kg. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Determination of NT pro BNP or BNP |  | 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 |