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Portico Valve-in-Valve Retrospective Registry

NCT05002088 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2025-02-28

Study results available
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Summary

The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Failure
  • Aortic Insufficiency
  • Aortic Stenosis

Interventions

DEVICE

Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2023-12-29
Completion
2023-12-29
FDA Device
Yes

Countries

  • Australia
  • Denmark
  • Germany
  • United Kingdom

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 NCT05002088 on ClinicalTrials.gov