Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

Launched by NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a method called Rapid Atrial Pacing (RAP) to see if it can help predict whether patients will need a permanent pacemaker after undergoing Transcatheter Aortic Valve Implantation (TAVI). TAVI is a procedure used to treat severe aortic stenosis, a condition where the heart's aortic valve narrows. Although TAVI is an advanced treatment, some patients may still require a pacemaker after the procedure. The trial aims to determine if RAP can be an effective way to identify those patients at risk of needing a pacemaker.

To participate in this study, you should be an adult at least 18 years old who is scheduled to have TAVI and is in a normal heart rhythm called sinus rhythm. You will need to understand the trial's purpose and agree to follow-up visits. If you have a current infection, already have a pacemaker, or have specific heart rhythm issues, you may not be eligible. Participants will receive close monitoring and care during the procedure, and their responses to RAP will help doctors learn more about managing heart health after TAVI.

Gender

ALL

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.