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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
France
Hôpital de la Timone - APHM
RECRUITING
Marseille
Contact Information
Primary
Baptiste MAILLE, MD
baptiste.maille@ap-hm.fr
491386576
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-05
Participants
Target number of participants: 360
Treatments
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.
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.
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov