RecruitingNot ApplicableNCT06189976

Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

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

Sponsor

National and Kapodistrian University of Athens

Enrollment

400 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Disease TAVI Transcatheter Aortic Valve Implantation

Summary

Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Adults ≥18 years old.
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.
Patient has given written consent to participate in the trial.
Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).
Patient in sinus rhythm.
Patients planned for TAVI with utilization of temporary pacemaker electrode placement.

Exclusion Criteria8

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