NCT06189976 Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
| NCT ID | NCT06189976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Aortic Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-03-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Leonidas Koliastasis
PRINCIPAL INVESTIGATOR
National and Kapodistrian University of Athens
Frequently Asked Questions
Who can join the NCT06189976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06189976 currently recruiting?
Yes, NCT06189976 is actively recruiting participants. Contact the research team at lkoliastasis@gmail.com for enrollment information.
Where is the NCT06189976 trial being conducted?
This trial is being conducted at Brussels, Belgium, Athens, Greece.
Who is sponsoring the NCT06189976 clinical trial?
NCT06189976 is sponsored by National and Kapodistrian University of Athens. The principal investigator is Leonidas Koliastasis at National and Kapodistrian University of Athens. The trial plans to enroll 400 participants.