MedTrace Logo

Feasibility Study of a Percutaneous Mitral Valve Repair System.

NCT00209339 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-11-07

Study results available
· View outcomes & findings →

Summary

Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.

Conditions

  • Mitral Valve Insufficiency
  • Mitral Valve Regurgitation
  • Mitral Valve Incompetence
  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

Percutaneous mitral valve repair (MitraClip Implant)

Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ted Feldman, M.D. · Endeavor Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2006-02-28
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00209339 on ClinicalTrials.gov