Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
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
Assistance Publique Hopitaux De Marseille
360 participants
Nov 12, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria17
- 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
- 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).
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Interventions
Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously
Locations(1)
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NCT06148883