Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
NCT05966675 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2025-06-08
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 progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Conditions
- Atrioventricular Block, Second and Third Degree
Interventions
- DEVICE
-
conduction system pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
- DEVICE
-
right ventricular or biventricular pacing
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Sponsors & Collaborators
-
Medical Research Agency, Poland
collaborator OTHER_GOV -
Medical University of Silesia
lead OTHER
Principal Investigators
-
Krzysztof S. Gołba, MD PhD · Silesian Medical University in Katowice
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-27
- Primary Completion
- 2028-05-31
- Completion
- 2028-06-30
Countries
- Poland
Study Locations
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