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COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

NCT00676689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-02-26

Study results available
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Summary

To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.

Conditions

  • Pulmonary Valve Insufficiency
  • Pulmonary Regurgitation
  • Dysfunctional RVOT Conduit
  • Pulmonary Obstruction
  • Pulmonary Stenosis

Interventions

DEVICE

SAPIEN Transcatheter Valve Implantation

Device Implantation

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Ziyad M Hijazi, M.D. · Rush University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-08
Primary Completion
2015-11-30
Completion
2019-12-31
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 NCT00676689 on ClinicalTrials.gov