Status:
RECRUITING
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Centre Hospitalier Universitaire Saint Pierre
Conditions:
Aortic Valve Disease
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 draw...
Detailed Description
1. INTRODUCTION AND RATIONALE Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06189976
Start Date
March 1 2024
End Date
December 31 2025
Last Update
December 12 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Saint-Pierre
Brussels, Belgium, 1000
2
Hippocration Hospital
Athens, Attica, Greece, 11527