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Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry

NCT03715894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-06-15

No results posted yet for this study

Summary

There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI

Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained with respect to the objectives of the registry.

Conditions

  • Aortic Valve Stenosis
  • AV Block
  • Bundle-Branch Block

Interventions

PROCEDURE

transcatheter valve implantation

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Tobias Geisler, Prof. · University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2022-10-15
Completion
2023-03-30

Countries

  • Germany
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715894 on ClinicalTrials.gov