LEANA: 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 Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)
|
Procedure: left bundle branch of His pacing
left bundle branch of His pacing
Procedure: right ventricular pacing
right ventricular pacing
|
| Experimental: right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)
|
Procedure: left bundle branch of His pacing
left bundle branch of His pacing
Procedure: right ventricular pacing
right ventricular pacing
|
Outcome Measures
Primary Outcome Measures
- Maximum Oxygen Consumption (VO2 max) in mL/min/kg. [18 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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).
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Rouen
Investigators
- Principal Investigator: Corentin CHAUMONT, MD, Rouen University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/0379/HP