Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (MONITORTAVI)

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.

Study Overview

• Status: Recruiting
• Conditions: Left Bundle-Branch Block
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baptiste MAILLE, MD; Phone Number: +33 491386576; Email: baptiste.maille@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13385
    • Recruiting
    • Hopital de la Timone - APHM
    • Contact: Baptiste MAILLE, MD; Phone Number: +33 491386576; Email: baptiste.maille@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :

1. 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
2. With an anticipated life expectancy >1 year
3. Who consent to participate to the study

Exclusion Criteria:

1. 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
2. Prior Pacemaker or Implantable Cardiac defibrillator
3. Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
4. Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
5. Pre-existing PR interval prolongation > 240 ms
6. Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination < 15
7. Pregnancy or breastfeeding patient
8. No affiliation to a social security scheme
9. Adult under legal protection (trusteeship, guardianship).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously
Experimental: Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation; In this group, Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms.	Procedure: Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 implantationAbsence of syncope or sudden cardiac deathAbsence of upgrading procedure	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bundle-Branch Block; Heart Block
• Other Study ID Numbers: 2022-A02699-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No