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Edwards SAPIEN 3 PPI Registry

NCT03497611 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2020-09-04

No results posted yet for this study

Summary

There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.

Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).

Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset 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
2018-04-30
Primary Completion
2018-11-03
Completion
2019-03-03

Countries

  • Germany

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 NCT03497611 on ClinicalTrials.gov