RECRUITINGINTERVENTIONAL

Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

Rapid atrial pacing

Rapid atrial pacing after TAVI

Locations (2)

CHU Saint-Pierre

Brussels, Belgium

Hippocration Hospital

Athens, Attica, Greece