Using rapid atrial pacing to predict the need for pacemaker implantation after TAVI

Rapid Atrial Pacing After TAVI as a Predictor of Permanent Pacemaker Implantation

This study is testing if a quick heart pacing method can help doctors predict which patients will need a permanent pacemaker after getting a new heart valve.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (Academic / other)
• Locations: 2 sites (Brussels and 1 other locations)
• Trial ID: NCT06189976 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of rapid atrial pacing (RAP) as a predictive tool for the necessity of permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). The study aims to assess the atrioventricular conduction system through RAP using a temporary pacemaker lead, which could provide valuable insights into patient management post-TAVI. By evaluating patients undergoing TAVI for severe aortic stenosis, the trial seeks to establish a reliable method for identifying those at risk of requiring PPI. The findings could help refine clinical decision-making and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing TAVI for severe aortic stenosis and are in sinus rhythm.

Not a fit: Patients with ongoing infections, those who already have a permanent pacemaker, or those who develop significant atrioventricular block after TAVI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better risk stratification for patients undergoing TAVI, potentially reducing unnecessary pacemaker implantations.

How similar studies have performed: While the approach of using rapid atrial pacing is relatively novel, existing studies have indicated the importance of electrophysiological testing in predicting PPI post-TAVI.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥18 years old.
2. Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
3. Patient has given written consent to participate in the trial.
4. Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).
5. Patient in sinus rhythm.
6. Patients planned for TAVI with utilization of temporary pacemaker electrode placement.

Exclusion Criteria:

1. Ongoing infection, including active endocarditis.
2. Implanted permanent pacemaker and/or implantable cardioverter/defibrillator.
3. Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.
4. Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.
5. Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.
6. Enrolment in another study that competes or interferes with this study.
7. Subject will not be able to comply with the follow-up requirements according to investigators' opinion.
8. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.

Where this trial is running

Brussels and 1 other locations

• CHU Saint-Pierre — Brussels, Belgium (Recruiting)
• Hippocration Hospital — Athens, Attica, Greece (Recruiting)

Study contacts

• Principal investigator: Leonidas Koliastasis — National and Kapodistrian University of Athens
• Study coordinator: Leonidas Koliastasis, MD, PhD

Conditions Aortic Valve Disease; Transcatheter Aortic Valve Implantation; TAVI; TAVR; Rapid atrial pacing; Aortic stenosis