Physiologic cardiac pacing to prevent heart weakening after TAVI
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
This trial will test whether using conduction system pacing instead of standard right‑ventricular or biventricular pacing can prevent heart failure and improve survival in adults who need a permanent pacemaker within 30 days after TAVI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 1 site (Katowice) |
| Trial ID | NCT05966675 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized head‑to‑head trial comparing permanent conduction system pacing (CSP) with standard right‑ventricular pacing (RVP) or biventricular pacing (BVP) in patients who develop high‑degree atrioventricular block or new complex conduction disturbances after TAVI. Eligible patients are those requiring a permanent pacemaker within 30 days after TAVI, implanted according to 2021 ESC pacing guidelines. Participants will be randomized to receive CSP or standard pacing and followed for clinical outcomes including development or progression of symptomatic chronic heart failure and survival. The trial is led by the Medical University of Silesia with planned follow‑up visits to monitor cardiac function and clinical events.
Who should consider this trial
Good fit: Adults (age ≥18) who had TAVI within the prior 30 days and meet ESC criteria for permanent pacemaker implantation because of high‑degree AV block or newly developed complex conduction disturbances are ideal candidates.
Not a fit: Patients who already had a permanent pacemaker before TAVI or who develop conduction disturbances more than 30 days after TAVI are not expected to benefit from this trial's intervention.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of post‑TAVI heart failure and improve survival by preserving more natural heart conduction.
How similar studies have performed: Small trials and registries in other pacemaker populations have suggested CSP better preserves left ventricular function compared with RVP, but its specific benefit after TAVI remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Katowice
- Medical University of Silesia in Katowice — Katowice, Poland (Recruiting)
Study contacts
- Study coordinator: Krzysztof S. Gołba, MD PhD
- Email: krzysztof.golba@gmail.com
- Phone: +48 (32)359-88-93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.