Status:
COMPLETED
Pivotal Study of a Percutaneous Mitral Valve Repair System
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip...
Detailed Description
Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair Syst...
Eligibility Criteria
Inclusion
- Key Inclusion/Exclusion Criteria:
- Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
- Are 18 years or older.
- Symptomatic
- If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
- Are candidates for mitral valve surgery
- Are candidates for transseptal catheterization
- Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
- Appropriate valve anatomy for MitraClip
- Does not need other cardiac surgery or any emergency surgery
- Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
- Mitral valve orifice area ≥ 4 cm2
- Do not have renal insufficiency
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT00209274
Start Date
August 1 2005
End Date
December 1 2014
Last Update
November 7 2018
Active Locations (1)
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1
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201