Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
Medical University of Silesia
500 participants
Feb 27, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05966675