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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
History of Changes
  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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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:
Evalve corporate web site  This link exits the ClinicalTrials.gov site
Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatments  This link exits the ClinicalTrials.gov site

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 June 18, 2013