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

Atrial Fibrillation Rapid Clinical Trial

— LEANA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061978
• Other study ID #: 2021/0379/HP
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: May 27, 2027

Study information

• Verified date: December 2023
• Source: University Hospital, Rouen
• Contact: Corentin CHAUMONT, MD
• Phone: 232888116
• Email: corentin.chaumont[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 27, 2027
• Est. primary completion date: May 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Rapid

Intervention

Procedure:
• left bundle branch of His pacing
left bundle branch of His pacing
• right ventricular pacing
right ventricular pacing

Locations

Country	Name	City	State
France	CHU de CAEN	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Oxygen Consumption (VO2 max) in mL/min/kg.		18 months
Secondary	walking test distance covered		18 months
Secondary	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
Secondary	Determination of NT pro BNP or BNP		18 months
Secondary	Physical component of quality-of-life scale (SF-36)		18 months
Secondary	Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP		18 months