Evaluating heart pacing to determine pacemaker needs after TAVI
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
This study is testing if certain heart rhythm changes during a pacing test can help doctors decide if TAVI patients will need a permanent pacemaker after their procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 12 sites (Aalst and 11 other locations) |
| Trial ID | NCT05278585 on ClinicalTrials.gov |
What this trial studies
This observational registry focuses on patients undergoing transcatheter aortic valve implantation (TAVI) to assess the predictive value of Wenckebach phenomena during rapid atrial pacing (RAP) for the need for permanent pacemaker (PPM) implantation. It aims to identify baseline and procedural characteristics associated with new conduction abnormalities and evaluate peri-procedural safety and outcomes after TAVI. By optimizing patient care and resource use, the study seeks to enhance early discharge protocols for TAVI patients. The findings could lead to improved decision-making regarding PPM implantation.
Who should consider this trial
Good fit: Ideal candidates are patients in sinus rhythm undergoing TAVI.
Not a fit: Patients in atrial fibrillation or those with a pre-existing pacemaker will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce unnecessary pacemaker implantations and hospital stays for TAVI patients.
How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in using RAP for risk stratification in pacemaker needs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients in sinus rhythm with TAVI Exclusion Criteria: * Patients in atrial fibrillation at the time of the implantation * Patients with pre-existent pacemaker
Where this trial is running
Aalst and 11 other locations
- Algemeen Stedelijk Ziekenhuis Aalst — Aalst, Belgium (Recruiting)
- OLV Aalst — Aalst, Belgium (Recruiting)
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
- AZ Sint Jan — Brugge, Belgium (Recruiting)
- CHU Charleroi-Chimay — Charleroi, Belgium (Recruiting)
- Grand Hôpital de Charleroi — Charleroi, Belgium (Recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
- UZ Brussel — Jette, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Citadelle Hospital — Liège, Belgium (Recruiting)
- Clinique Saint-Luc Bouge — Namur, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
Study contacts
- Principal investigator: Ian Buysschaert, MD, PhD — AZ Sint Jan
- Study coordinator: Ian Buysschaert, MD, PhD
- Email: ian.buysschaert@azsintjan.be
- Phone: +32050452670
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.