Atrioventricular BlockLBAP-TAVINCT07236489
Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
A study testing Pacemaker implantation using left bundle branch area stimulation and Right ventricular pacemaker implantation in people with Atrioventricular Block and Pacemaker, run by Nantes University Hospital at 7 sites in France.
Trial summary
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block, Pacemaker
- What is being tested?
- Pacemaker implantation using left bundle branch area stimulation and Right ventricular pacemaker implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 7 sitesFrance
- Study dates
- 25 Nov 2025to Nov 2029
- 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
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- Indications for pacemaker implantation according to guidelines, including :
- Third-degree atrioventricular (AV) block
- Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
- Alternating left and right bundle branch block
Show all 11Show fewer
- HV interval ≥ 70 ms during electrophysiological study
- Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI
- Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation
- Signed informed consent
- Patient affiliated with the national health insurance system
Who cannot join
- Left ventricular ejection fraction (LVEF) < 50% before TAVI
- Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- Previously implanted pacemaker
- Patients under legal guardianship, curatorship, or judicial protection
- Participation in another interventional therapeutic clinical trial
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Brest University Hospital
Brest, Finistère, 29200
Jacques MANSOURATI, UH Practitioner, +33298347405, Jacques.mansourati@gmail.com
Jacques MANSOURATI, UH Practitioner
- Not yet recruiting
Clermont Ferrand University Hospital
Clermont-Ferrand, Puy-de-Dôme, 63003
Romain ESCHALIER, UH Practitioner, +33473751410, reschalier@chuclermontferrand.fr
Romain ESCHALIER, UH Practitioner
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Damien MINOIS, M.D, +33244768742, damien.minois@chu-nantes.fr
Damien MINOIS, M.D
- Recruiting
Poitiers University Hospital
Poitiers, Vienne, 86021
Rodrigue GARCIA, UH Practitioner, +33603847546, Rodrigue_garcia@hotmail.fr
Rodrigue GARCIA, UH Practitioner
- Recruiting
Rennes University Hospital
Rennes, Ille-et-Vilaine, 35033
Nathalie BEHAR, M.D, +33299282517, Nathalie.behar@chu-rennes.fr
Nathalie BEHAR, M.D
- Recruiting
Rouen University Hospital
Rouen, Seine-Maritime, 76031
Frédéric ANSELME, UH Practitioner, +33235521638, Frederic.anselme@chu-rouen.fr
Frédéric ANSELME, UH Practitioner
- Recruiting
Tours University Hospital
Tours, Indre-et-Loire, 37044
Arnaud BISSON, M.D, +33247474787, a.bisson@chu-tours.fr
Arnaud BISSON, M.D
About this study
Official title: Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality.
Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing.
The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
- Conditions
- Atrioventricular Block, Pacemaker
- Being tested
- Pacemaker implantation using left bundle branch area stimulation, Right ventricular pacemaker implantation
- Keywords
- Pacemaker, Atrioventricular block, TAVI, LBAP
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation using left bundle branch area stimulationProcedure or surgery
Pacemaker implantation using left bundle branch area stimulation
Right ventricular pacemaker implantationProcedure or surgery
Right ventricular pacemaker implantation
| Study group | Role | What they receive |
|---|---|---|
| LBAP : Left Bundle Area Pacing | Experimental | Pacemaker implantation using left bundle branch area stimulation Receives: Procedure: Pacemaker implantation using left bundle branch area stimulation |
| RVP : Right Ventricular Pacing | Placebo comparator | Right ventricular pacemaker implantation Receives: Procedure: Right ventricular pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cardiovascular deaths
Measured: 24 months
number of hospitalizations for heart failure
Measured: 24 months
number of surgical reinterventions
Measured: 24 months
Secondary outcomes (10)
success rate of the LBAP technique
Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect
Measured: 3, 12, and 24 months post-implantation
comparison of immediate and long-term complications of the LBAP stimulation
Adverse events such as: pneumothorax, infection of equipment, displacement of atrial catheter, lumen haematoma, venous thrombosis, pericardial effusion, reoperation, vascular complication, catheter-specific complications
Measured: 3, 12, and 24 months post-implantation
ECG measurements
QRS duration (ms)
Measured: 3, 12, and 24 months post-implantation
left ventricular function (LVEF)
Measured: 3, 12, and 24 months post-implantation
left ventricular diameter
Measured: 3, 12, and 24 months post-implantation
creatinine levels
Measured: 3, 12, and 24 months post-implantation
GFR in CKD EPI
Measured: 3, 12, and 24 months post-implantation
Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.
Measured: 3, 12, and 24 months post-implantation
EQ-5D-5L questionnaire.
Measured: Baseline (inclusion), 3, 12, and 24 months post-treatment
Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.
This will be calculated from EQ-5D-5L utility scores.
Measured: 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start25 Nov 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236489
- Sponsor's protocol ID
- RC24_0610
- Acronym
- LBAP-TAVI
- Status last verified
- Apr 2026
- First submitted
- 8 Sep 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
- ClinicalTrials.gov ID
- NCT07236489
- Acronym / sponsor ID
- LBAP-TAVI / RC24_0610
- Conditions
- Atrioventricular Block, Pacemaker
- Keywords
- Pacemaker, Atrioventricular block, TAVI, LBAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 19 Nov 2025 (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.
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality.
Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing.
The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBAP : Left Bundle Area Pacing | Experimental | Procedure: Pacemaker implantation using left bundle branch area stimulationPacemaker implantation using left bundle branch area stimulation |
| RVP : Right Ventricular Pacing | Placebo comparator | Procedure: Right ventricular pacemaker implantationRight ventricular pacemaker implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- Indications for pacemaker implantation according to guidelines, including :
- Third-degree atrioventricular (AV) block
- Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
Key exclusion criteria (5 listed)
- Left ventricular ejection fraction (LVEF) < 50% before TAVI
- Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- Previously implanted pacemaker
- Patients under legal guardianship, curatorship, or judicial protection
- Participation in another interventional therapeutic clinical trial
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 |
|---|---|---|
| Pacemaker implantation using left bundle branch area stimulationPacemaker implantation using left bundle branch area stimulation | Procedure or surgery | LBAP : Left Bundle Area Pacing |
| Right ventricular pacemaker implantationRight ventricular pacemaker implantation | Procedure or surgery | RVP : Right Ventricular Pacing |
Primary outcome
number of cardiovascular deaths
Time frame: 24 months
number of hospitalizations for heart failure
Time frame: 24 months
number of surgical reinterventions
Time frame: 24 months
10 secondary outcomes
success rate of the LBAP technique
Time frame: 3, 12, and 24 months post-implantation
comparison of immediate and long-term complications of the LBAP stimulation
Time frame: 3, 12, and 24 months post-implantation
ECG measurements
Time frame: 3, 12, and 24 months post-implantation
left ventricular function (LVEF)
Time frame: 3, 12, and 24 months post-implantation
left ventricular diameter
Time frame: 3, 12, and 24 months post-implantation
creatinine levels
Time frame: 3, 12, and 24 months post-implantation
GFR in CKD EPI
Time frame: 3, 12, and 24 months post-implantation
Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.
Time frame: 3, 12, and 24 months post-implantation
EQ-5D-5L questionnaire.
Time frame: Baseline (inclusion), 3, 12, and 24 months post-treatment
Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.
Time frame: 24 months post-implantation
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 15 Apr 2026.
Related trials for Atrioventricular Block
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Recruiting
Novel Approach to Conduction System Pacing With Use of Ultrasound
Conduction Block, Atrioventricular, Bundle-Branch Block
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation using left bundle branch area stimulation and Right ventricular pacemaker implantation in people with Atrioventricular Block and Pacemaker, run by Nantes University Hospital at 7 sites 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 11 inclusion and 5 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 Research and Innovation Departement of Nantes UH (+33253482810, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cardiovascular deaths (time frame: 24 months). The study lists 3 primary outcomes in all. 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 15 Apr 2026.