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ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

NCT03143686 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2018-03-19

No results posted yet for this study

Summary

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

Conditions

  • Symptomatic Aortic Stenosis

Interventions

DEVICE

ACURATE TA™ Transapical Aortic Bioprosthesis

ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.

Sponsors & Collaborators

  • Symetis SA

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31
Completion
2013-11-30

Countries

  • Argentina
  • Germany
  • Italy
  • Switzerland

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 NCT03143686 on ClinicalTrials.gov