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Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve

NCT02127580 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-04-27

No results posted yet for this study

Summary

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry.

We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

BAV

PROCEDURE

without BAV

Sponsors & Collaborators

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Holger Schröfel, MD · Clinic for Cardiac Surgery Karlsruhe

  • Justus Strauch, Prof. · Klinik für Herz- und Thoraxchirurgie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-05-31

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 NCT02127580 on ClinicalTrials.gov