Feasibility Study of a Percutaneous Mitral Valve Repair System. (EVEREST(I))

This study has been completed.
Sponsor:
Information provided by:
Evalve
ClinicalTrials.gov Identifier:
NCT00209339
First received: September 13, 2005
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Device: Percutaneous mitral valve repair (MitraClip Implant)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Resource links provided by NLM:


Further study details as provided by Evalve:

Primary Outcome Measures:
  • Acute safety at 30 days, defined as freedom from major adverse events (MAE), defined as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed Clip, Clip detachment, stroke and septicemia. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 30 day and 6-month assessment of mitral regurgitation severity determined by echocardiography. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: July 2003
Study Completion Date: October 2011
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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 Cardovascular Valve Repair System.
    Other Name: EVEREST I, MitraClip
Detailed Description:

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

The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.

Up to 12 clinical sites throughout the US may participate.

The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction;
  • Experience regurgitation origination from the central two-thirds of the valve;
  • Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.

Exclusion Criteria:

  • Ejection fraction < 30%
  • Endocarditis
  • Rheumatic heart disease
  • Renal insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209339

Locations
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Evalve
Investigators
Principal Investigator: Ted Feldman, M.D. NorthShore University HealthSystem Research Institute
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth McDermott, Divisional Vice President of Regulatory and Clinical Affairs, Abbott Vascular Structural Heart (Evalve, Inc)
ClinicalTrials.gov Identifier: NCT00209339     History of Changes
Other Study ID Numbers: Protocol #0301, Protocol #0301
Study First Received: September 13, 2005
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Evalve:
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
Mitral Valve Prolapse
E2E - Edge to Edge
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
EVEREST
EVEREST I
EVEREST II

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014