Status:
RECRUITING
Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
Lead Sponsor:
University Hospital, Rouen
Conditions:
Atrial Fibrillation Rapid
Eligibility:
All Genders
18+ years
Phase:
NA
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 atrioventric...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 27 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06061978
Start Date
November 27 2023
End Date
May 27 2027
Last Update
December 5 2023
Active Locations (1)
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1
CHU de CAEN
Caen, France