Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rapid atrial pacing
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
National and Kapodistrian University of Athens
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborator
Source ClinicalTrials.gov