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Recruiting NCT06148883

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

Trial Parameters

Condition Left Bundle-Branch Block
Sponsor Assistance Publique Hopitaux De Marseille
Study Type INTERVENTIONAL
Phase N/A
Enrollment 360
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-12
Completion 2027-05
Interventions
Transcatheter Aortic Valve Implantation

Brief 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 Criteria

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 Implanta

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