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Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)

NCT02339974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-18

Study results available
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Summary

The goal of this study is to determine the short term safety (\<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at a very high surgical risk for tricuspid valve replacement.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Brian P O'Neill, MD · Henry Ford Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

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 NCT02339974 on ClinicalTrials.gov