Left Bundle-Branch BlockMONITORTAVINCT06148883
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
A study testing Transcatheter Aortic Valve Implantation in people with Left Bundle-Branch Block, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle-Branch Block
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2024to 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
- Patients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :
- Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block >150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable
- With an anticipated life expectancy >1 year
- Who consent to participate to the study
Who cannot join
- During in-hospital Electrocardiogram monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:
- Documented high grade Atrio Ventricular block (Atrio Ventricular block of a degree higher than Mobitz I)
- Persistent PR interval prolongation > 240 ms
- Occurrence of syncope or sudden cardiac death,
- Identification of any indisputable criteria for Pacemaker implantation
- Definitive Pacemaker implantation
Show all 14Show fewer
- Prior Pacemaker or Implantable Cardiac defibrillator
- Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
- Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
- Pre-existing PR interval prolongation > 240 ms
- Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination < 15
- Pregnancy or breastfeeding patient
- No affiliation to a social security scheme
- Adult under legal protection (trusteeship, guardianship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Timone - APHM
Marseille, 13385
Baptiste MAILLE, MD, 491386576 ext. +33, baptiste.maille@ap-hm.fr
About this study
Official title: Comparison of Early Ambulatory Monitoring Strategy Versus Electrophysiological Study Approach in the Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.
Read the detailed description
This is a prospective, multicentric, randomized in parallel group, controlled, open labelled clinical study.
- After Transcatheter Aortic Valve Implantation, all consecutive patients presenting with new onset Left Bundle Branch Block will undergo in-hospital telemetry. In case of persistence (at least 48 hours) of a stable (i.e., no change in the last 24 hours) Left Bundle Branch Block > 150 ms, and in the absence of high grade Aortic Valve block or persistent prolonged PR interval > 240 ms, patients will be eligible for the study
- After written consent will be obtained, included patients will be randomized into two groups according to a 1:1 ratio:
- Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge. In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. Any other clinically relevant therapeutic decision based on Electrocardiogram Ambulatory Monitoring will be taken or
- ElectroPhysiological Study for infra-hisian conduction evaluation. Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms
- Patients in both groups will be followed until the end of the first year after randomization. Follow-up visits will be scheduled in person at 1 and 12 months, and through telemedicine at 3 and 6 months. Appropriateness of Pacemaker implantation/non-implantation will be evaluated at each follow-up time
- In case of any occurrence of syncope, patients will be evaluated in person, by the principal investigator of each centre, to evaluate and manage the syncope as recommended by the European Society of Cardiology guidelines.
Patients will be followed-up according to current practice.
- Conditions
- Left Bundle-Branch Block
- Being tested
- Transcatheter Aortic Valve Implantation
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationProcedure or surgery
Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously
| Study group | Role | What they receive |
|---|---|---|
| Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge | Active comparator | In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. Receives: Procedure: Transcatheter Aortic Valve Implantation |
| Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation | Experimental | In this group, Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms. Receives: Procedure: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive status with appropriate Pacemaker implantation/non-implantation
The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization.
- Appropriate Pacemaker non-implantation:
- Absence of syncope or sudden cardiac death in a non-implanted patient
- Appropriate Pacemaker implantation:
- Documented indisputable criteria for Pacemaker implantation
- Absence of syncope or sudden cardiac death
- Absence of upgrading procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start12 Nov 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle-Branch BlockStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Parallel groups
- Model description
- This is a randomized in 2 parallel group study
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148883
- Sponsor's protocol ID
- 2022-A02699-34
- Acronym
- MONITORTAVI
- Status last verified
- Jun 2025
- First submitted
- 20 Nov 2023
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Ambulatory Monitoring Strategy Versus Electrophysiological Study Approach in the Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT06148883
- Acronym / sponsor ID
- MONITORTAVI / 2022-A02699-34
- Conditions
- Left Bundle-Branch Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Nov 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 purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.
Detailed description
This is a prospective, multicentric, randomized in parallel group, controlled, open labelled clinical study.
- After Transcatheter Aortic Valve Implantation, all consecutive patients presenting with new onset Left Bundle Branch Block will undergo in-hospital telemetry. In case of persistence (at least 48 hours) of a stable (i.e., no change in the last 24 hours) Left Bundle Branch Block > 150 ms, and in the absence of high grade Aortic Valve block or persistent prolonged PR interval > 240 ms, patients will be eligible for the study
- After written consent will be obtained, included patients will be randomized into two groups according to a 1:1 ratio:
- Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge. In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. Any other clinically relevant therapeutic decision based on Electrocardiogram Ambulatory Monitoring will be taken or
- ElectroPhysiological Study for infra-hisian conduction evaluation. Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms
- Patients in both groups will be followed until the end of the first year after randomization. Follow-up visits will be scheduled in person at 1 and 12 months, and through telemedicine at 3 and 6 months. Appropriateness of Pacemaker implantation/non-implantation will be evaluated at each follow-up time
- In case of any occurrence of syncope, patients will be evaluated in person, by the principal investigator of each centre, to evaluate and manage the syncope as recommended by the European Society of Cardiology guidelines.
Patients will be followed-up according to current practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized in 2 parallel group study
| Arm | Type | Receives |
|---|---|---|
| Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge | Active comparator | Procedure: Transcatheter Aortic Valve ImplantationIn this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. |
| Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation | Experimental | Procedure: Transcatheter Aortic Valve ImplantationIn this group, Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block >150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable
- With an anticipated life expectancy >1 year
- Who consent to participate to the study
Key exclusion criteria (14 listed)
- During in-hospital Electrocardiogram monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:
- Prior Pacemaker or Implantable Cardiac defibrillator
- Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
- Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
- Pre-existing PR interval prolongation > 240 ms
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationTranscatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously | Procedure or surgery | Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge, Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation |
Primary outcome
Alive status with appropriate Pacemaker implantation/non-implantation
Time frame: 12 months
The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization. * Appropriate Pacemaker non-implantation: - Absence of syncope or sudden cardiac death in a non-implanted patient * Appropriate Pacemaker implantation: * Documented indisputable criteria for Pacemaker implantation * Absence of syncope or sudden cardiac death * Absence of upgrading procedure
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 1 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation in people with Left Bundle-Branch Block, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 14 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 1 Jul 2025. 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 Baptiste MAILLE, MD (491386576 ext. +33, baptiste.maille@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive status with appropriate Pacemaker implantation/non-implantation (time frame: 12 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 1 Jul 2025.