Actively Recruiting
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-07-01
360
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older who have undergone Transcatheter Aortic Valve Implantation
- New Onset Persistent Left Bundle Branch Block lasting at least 2 days after implantation and stable, with QRS duration >150 ms
- Anticipated life expectancy greater than 1 year
- Provided written consent to participate in the study
You will not qualify if you...
- Documented high grade Atrio Ventricular block (higher than Mobitz I) during in-hospital ECG monitoring after valve implantation
- Persistent PR interval prolongation greater than 240 ms during in-hospital monitoring
- Occurrence of syncope or sudden cardiac death before inclusion
- Any clear indication for pacemaker implantation before inclusion
- Existing pacemaker implantation
- Prior pacemaker or implantable cardiac defibrillator
- Indication for Cardiac Resynchronization Therapy or implantable cardiac defibrillator
- Pre-existing Left or Right Bundle Branch Block
- Pre-existing PR interval prolongation greater than 240 ms
- Moderate or severe dementia before valve implantation (Mini Mental State Examination score <15)
- Pregnancy or breastfeeding
- No affiliation with a social security scheme
- Adults under legal protection such as trusteeship or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital de la Timone - APHM
Marseille, France, 13385
Actively Recruiting
Research Team
B
Baptiste MAILLE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here