Status:
RECRUITING
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Left Bundle-Branch Block
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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).
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06148883
Start Date
November 12 2024
End Date
May 1 2027
Last Update
July 1 2025
Active Locations (1)
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1
Hôpital de la Timone - APHM
Marseille, France, 13385