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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)

Primary Purpose

Atrial Fibrillation Rapid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
left bundle branch of His pacing
right ventricular pacing
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation Rapid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)

    right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maximum Oxygen Consumption (VO2 max) in mL/min/kg.

    Secondary Outcome Measures

    walking test distance covered
    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)
    Determination of NT pro BNP or BNP
    Physical component of quality-of-life scale (SF-36)
    Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061978
    Brief 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
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2027 (Anticipated)
    Study Completion Date
    April 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Rapid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)
    Arm Type
    Experimental
    Arm Title
    right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    left bundle branch of His pacing
    Intervention Description
    left bundle branch of His pacing
    Intervention Type
    Procedure
    Intervention Name(s)
    right ventricular pacing
    Intervention Description
    right ventricular pacing
    Primary Outcome Measure Information:
    Title
    Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    walking test distance covered
    Time Frame
    18 months
    Title
    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
    Title
    Determination of NT pro BNP or BNP
    Time Frame
    18 months
    Title
    Physical component of quality-of-life scale (SF-36)
    Time Frame
    18 months
    Title
    Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Corentin CHAUMONT, MD
    Phone
    232888116
    Ext
    +33
    Email
    corentin.chaumont@chu-rouen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Armelle GUIDOTTI
    Phone
    232888265
    Ext
    +33
    Email
    armelle.guidotti@chu-rouen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Corentin CHAUMONT, MD
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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