Status:
RECRUITING
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Atrioventricular Block, Second and Third Degree
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progress...
Detailed Description
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RV...
Eligibility Criteria
Inclusion
- transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
- Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
- Written informed consent
- Age of at least 18 years
Exclusion
- Permanent pacemaker implantation before TAVI procedure
- The occurrence of conduction disturbances more than 30 days after TAVI procedure
- No written informed consent
- Inability to obtain informed consent from participant
- Predicted inability to obtain cooperation from patient during observation period
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05966675
Start Date
February 27 2024
End Date
June 1 2028
Last Update
June 8 2025
Active Locations (1)
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1
Medical University of Silesia in Katowice
Katowice, Poland