Atrial Fibrillation RapidLEANANCT06061978
Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation
A study testing left bundle branch of His pacing and right ventricular pacing in people with Atrial Fibrillation Rapid, run by University Hospital, Rouen at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Rapid
- What is being tested?
- left bundle branch of His pacing and right ventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to 27 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Atrial Fibrillation Rapid
- Being tested
- left bundle branch of His pacing, right ventricular pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left bundle branch of His pacingProcedure or surgery
left bundle branch of His pacing
right ventricular pacingProcedure or surgery
right ventricular pacing
| Study group | Role | What they receive |
|---|---|---|
| left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP) | Experimental | Not described Receives: Procedure: left bundle branch of His pacing; Procedure: right ventricular pacing |
| right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP) | Experimental | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
Measured: 18 months
Secondary outcomes (5)
walking test distance covered
Measured: 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)
Measured: 18 months
Determination of NT pro BNP or BNP
Measured: 18 months
Physical component of quality-of-life scale (SF-36)
Measured: 18 months
Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start27 Nov 2023
- Primary completion27 May 2027 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RapidStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corentin CHAUMONT, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061978
- Sponsor's protocol ID
- 2021/0379/HP
- Acronym
- LEANA
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06061978
- Acronym / sponsor ID
- LEANA / 2021/0379/HP
- Conditions
- Atrial Fibrillation Rapid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP) | Experimental | Procedure: left bundle branch of His pacing, Procedure: right ventricular pacing |
| right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP) | Experimental | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left bundle branch of His pacingleft bundle branch of His pacing | Procedure or surgery | left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP) |
| right ventricular pacingright ventricular pacing | Procedure or surgery | left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP) |
Primary outcome
Maximum Oxygen Consumption (VO2 max) in mL/min/kg.
Time frame: 18 months
5 secondary outcomes
walking test distance covered
Time frame: 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)
Time frame: 18 months
Determination of NT pro BNP or BNP
Time frame: 18 months
Physical component of quality-of-life scale (SF-36)
Time frame: 18 months
Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corentin CHAUMONT, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left bundle branch of His pacing and right ventricular pacing in people with Atrial Fibrillation Rapid, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corentin CHAUMONT, MD (232888116 ext. +33, corentin.chaumont@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Oxygen Consumption (VO2 max) in mL/min/kg. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.