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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation Rapid
• Intervention / Treatment: Procedure: left bundle branch of His pacing; Procedure: right ventricular pacing

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corentin CHAUMONT, MD; Phone Number: +33 232888116; Email: corentin.chaumont@chu-rouen.fr
• Study Contact Backup: Name: Armelle GUIDOTTI; Phone Number: +33 232888265; Email: armelle.guidotti@chu-rouen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU de Caen
    • Contact: Pierre OLLITRAULT, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Corentin CHAUMONT, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2021/0379/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No