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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lkoliastasis@gmail.com
• Phone: +30 6974270752

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.