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Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

ConditionsAortic Valve DiseaseTranscatheter Aortic Valve ImplantationTAVI
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Rapid atrial pacing

    Diagnostic test

    Rapid atrial pacing after TAVI

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Rapid atrial pacingOther 1 intervention

Trial outcomes

Primary outcomes

1

Permanent pacemaker implantation rates

Rates of permanent pacemaker implantation after TAVI

Time frame
30 days

Secondary outcomes

1

Mortality rates

Rates of mortality after TAVI

Time frame
30 days
2

Mortality rates

Rates of mortality after TAVI

Time frame
6 months
3

Permanent pacemaker implantation rates

Rates of permanent pacemaker implantation after TAVI

Time frame
6 months
4

Mortality rates

Rates of mortality after TAVI

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National and Kapodistrian University of Athens

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Collaborator

Source ClinicalTrials.gov
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