Clinical Trials Logo

Clinical 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 Branch Block after Transcatheter Aortic Valve Implantation.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06148883
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact Baptiste MAILLE, MD
Phone 491386576
Email baptiste.maille@ap-hm.fr
Status Not yet recruiting
Phase N/A
Start date November 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT03614169 - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB N/A
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Completed NCT03567096 - LV Only MPP With SyncAV N/A
Enrolling by invitation NCT05903313 - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Completed NCT04221763 - Mechanisms and Innovations in Cardiac Resynchronisation Therapy N/A
Recruiting NCT03303612 - Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI N/A
Recruiting NCT05572957 - LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB N/A
Recruiting NCT05769036 - Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients N/A
Completed NCT04537455 - Non-invasive Mapping Using Ultra-high Frequency Electrocardiography N/A
Active, not recruiting NCT05572736 - Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure Phase 3
Recruiting NCT03415945 - Left Ventricular Septal Pacing: Potential Application for Cardiac Resynchronization Therapy N/A
Completed NCT02326493 - Tailor-CRT: Better Application of Cardiac Resynchronization Therapy N/A
Recruiting NCT01415024 - Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication Phase 4
Not yet recruiting NCT04328649 - Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block.
Not yet recruiting NCT05760924 - Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders N/A
Recruiting NCT05327062 - Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment N/A
Completed NCT03803995 - Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block N/A
Recruiting NCT05434962 - The Left Bundle Cardiac Resynchronization Therapy Trial N/A
Recruiting NCT04128384 - Infranodal Conduction Time During TAVR as Predictor of HAVB N/A
Recruiting NCT05884359 - Left Bundle Branch Area Mapping for Conduction System Pacing