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Clinical Trials in Poland / NCT05966675
Recruiting Not applicable

Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

NCT05966675 · tracked via the Priya Life Science Poland tracker
Sponsor
Medical University of Silesia
Phase
Not applicable
Started
2024-02-27
Last updated
2025-06-08

Condition(s) studied

Atrioventricular Block, Second and Third Degree

Investigational drug(s) / intervention(s)

conduction system pacingright ventricular or biventricular pacing

conduction system pacing: Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation 2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines 3. Written informed consent 4. Age of at least 18 years Exclusion Criteria: 1. Permanent pacemaker implantation before TAVI procedure 2. The occurrence of conduction disturbances more than 30 days after TAVI procedure 3. No written informed consent 4. Inability to obtain informed consent from participant 5. Predicted inability to obtain cooperation from patient during observation period

Primary outcome measure(s)

  • Heart Failure Hospitalization — 12 months
    Hospitalization due to heart failure as a main reason
  • All-cause death — 12 months
    Death from any cause

Trial sites (1)

FacilityCityRegionStatus
Medical University of Silesia in Katowice Katowice Poland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05966675 on ClinicalTrials.gov ↗ ← All trials in Poland