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NCT Number: NCT06061978

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de CAEN

Caen, France

Location status: Recruiting

Location contact

Pierre OLLITRAULT, Pr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

  • 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

Treatment and study plan

left bundle branch of His pacing

Procedure

left bundle branch of His pacing

Right ventricular pacing

Procedure

right ventricular pacing

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

  1. walking test distance covered

    Time frame: 18 months

  2. 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

  3. Determination of NT pro BNP or BNP

    Time frame: 18 months

  4. Physical component of quality-of-life scale (SF-36)

    Time frame: 18 months

  5. Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle GUIDOTTI

CONTACT

[email protected]

232888265 ext. +33

Corentin CHAUMONT, MD

CONTACT

[email protected]

232888116 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: LEANA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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