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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

NCT03225001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2021-03-09

Study results available
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Summary

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Conditions

  • Aortic Stenosis
  • Cardiomyopathy, Hypertrophic

Interventions

DEVICE

Edwards SAPIEN XT transcatheter valve, Model 9300TFX

Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • John Webb, MD · St. Paul's Hospital, Vancouver, British columbia, Canada

  • Michael Mack, MD · Baylor Heart Hospital, Plano, TX

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-11
Primary Completion
2016-12-16
Completion
2020-10-28
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03225001 on ClinicalTrials.gov