Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: left bundle branch of His pacing, right ventricular pacing.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation Rapid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Procedure left bundle branch of His pacing
left bundle branch of His pacing - Procedure right ventricular pacing
right ventricular pacing
Primary outcome measures
- Maximum Oxygen Consumption (VO2 max) in mL/min/kg. [Time frame: 18 months]
Secondary outcome measures (5)
- walking test distance covered [Time frame: 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) [Time frame: 18 months]
- Determination of NT pro BNP or BNP [Time frame: 18 months]
- Physical component of quality-of-life scale (SF-36) [Time frame: 18 months]
- Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP [Time frame: 18 months]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de CAEN — Caen
Identifiers
NCT: NCT06061978 · 2021/0379/HP