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Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
RECRUITINGN/ASponsored by Assistance Publique Hopitaux De Marseille
Actively Recruiting
PhaseN/A
SponsorAssistance Publique Hopitaux De Marseille
Started2024-11-12
Est. completion2027-05
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06148883
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
Age: 18 Years+Healthy volunteers accepted
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 Implantable cardiac defibrillator 4. Pre-existing Left Bundle Branch Block or Right Bundle Branch Block 5. Pre-existing PR interval prolongation \> 240 ms 6. Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination \< 15 7. Pregnancy or breastfeeding patient 8. No affiliation to a social security scheme 9. Adult under legal protection (trusteeship, guardianship).
Conditions2
Heart DiseaseLeft Bundle-Branch Block
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Actively Recruiting
PhaseN/A
SponsorAssistance Publique Hopitaux De Marseille
Started2024-11-12
Est. completion2027-05
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06148883