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CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

NCT02209298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 202

Last updated 2019-04-16

No results posted yet for this study

Summary

This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

CoreValve Transcatheter Valve

Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Didier Tchetche, Dr. · Clinique Pasteur Toulouse

  • Jean-Philippe Verhoye, Prof. · Centre Hospitalier Universitaire, Rennes

  • Ran Kornowski, Prof. · Rabin Medical Center, Tel Aviv

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-30
Completion
2018-12-03

Countries

  • France
  • Germany
  • Israel
  • Italy

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 NCT02209298 on ClinicalTrials.gov