Clinical trial NCT00209274: Pivotal Study of a Percutaneous Mitral Valve Repair System
Official title: Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Keywords: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
Mitral Valve Prolapse
Edge to Edge (E2E)
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
EVEREST
EVEREST I
EVEREST II
REALISM
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

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 System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Major Adverse Events (MAE)
timeFrame: 30 days
measure: Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
timeFrame: 12 months
Secondary outcomes:
measure: Freedom From All-Cause Mortality
timeFrame: 12 months
measure: Freedom From All-Cause Mortality
timeFrame: 24 months
measure: Freedom From All-Cause Mortality
timeFrame: 3 years
measure: Freedom From All-Cause Mortality
timeFrame: 4 years
measure: Freedom From All-Cause Mortality
timeFrame: 5 years
measure: Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
timeFrame: 12 months
measure: Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
timeFrame: 24 months
measure: Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
timeFrame: 24 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At discharge (≤ 14 days following index procedure) or 30 days
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 12 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 24 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 3 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 4 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 5 years
measure: Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
timeFrame: 30 days
measure: Left Ventricular Status- LVEDV, LVESV
timeFrame: 12 months
measure: Left Ventricular Status- LVEDV, LVESV
timeFrame: 24 months
measure: Left Ventricular Status- LVEDV, LVESV
timeFrame: 3 years
measure: Left Ventricular Status- LVEDV, LVESV
timeFrame: 4 years
measure: Left Ventricular Status- LVEDV, LVESV
timeFrame: 5 years
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 30 days
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 12 months
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 2 years
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 3 years
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 4 years
measure: Left Ventricular Internal Dimension Systole (LVIDs)
timeFrame: 5 years
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 30 days
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 12 months
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 24 months
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 3 years
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 4 years
measure: Left Ventricular Internal Dimension Diastole (LVIDd)
timeFrame: 5 years
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: Baseline
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 30 days
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 12 months
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 24 months
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 3 years
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 4 years
measure: Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
timeFrame: 5 years
measure: New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 30 days
measure: Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 12 months
measure: Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 2 years
measure: Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 3 years
measure: Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 4 years
measure: Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
timeFrame: 5 years
measure: Short Form (SF)-36 Quality of Life Questionnaire.
timeFrame: 30 days
measure: Short Form (SF)-36 Quality of Life Questionnaire.
timeFrame: 12 months
measure: Cardiac Output
timeFrame: 30 days
measure: Cardiac Output
timeFrame: 12 months
measure: Cardiac Output
timeFrame: 24 months
measure: Cardiac Index
timeFrame: 30 days
measure: Cardiac Index (CI)
timeFrame: 12 months
measure: Cardiac Index
timeFrame: 24 months
measure: Regurgitant Volume
timeFrame: 30 Days
measure: Regurgitant Volume
timeFrame: 12 months
measure: Regurgitant Volume
timeFrame: 24 months
measure: Regurgitant Fraction (RF)
timeFrame: 30 Days
measure: Regurgitant Fraction
timeFrame: 12 months
measure: Regurgitant Fraction
timeFrame: 24 months
measure: Number of Participants With Clip Implant Rate
timeFrame: Day 0
measure: Number of Participants With Acute Procedural Success
timeFrame: 30 Days
measure: Number of Participants With Acute Surgical Success
timeFrame: 30 Days
measure: Number of Participants With Successful Clip Implant and Acute Procedural Success
timeFrame: 30 days
measure: Number of Participants With Mitral Valve Repair Success.
timeFrame: 12 months
measure: Number of Participants With Mitral Valve Repair Success.
timeFrame: 24 months
measure: Number of Participants With Procedural Freedom From In-hospital MAE.
timeFrame: Day 0
measure: Number of Participants With Procedural Freedom From In-hospital MAE
timeFrame: Day 30
measure: Number of Participants With MAE: Surgery After Device and First Time Surgery Control
timeFrame: 30 days
measure: Number of Participants With Major Vascular Complications
timeFrame: 30 days
measure: Number of Participants With Major Vascular Complications
timeFrame: 12 months
measure: Number of Participants With Major Bleeding Complications.
timeFrame: 30 days
measure: Number of Participants With Major Bleeding Complications.
timeFrame: 12 months
measure: Number of Participants With Major Adverse Events (MAE)
timeFrame: 12 months.
measure: Number of Participants With MAE in Patients Over 75 Years of Age.
timeFrame: 30 days
measure: Number of Participants With MAE in Patients Over 75 Years of Age.
timeFrame: 12 months
measure: Number of Participants With Dysrhythmia
timeFrame: 30 days
measure: Number of Participants With Dysrhythmia
timeFrame: 12 months
measure: Number of Participants With Endocarditis.
timeFrame: 30 days
measure: Number of Participants With Endocarditis.
timeFrame: 12 months
measure: Number of Participants With Thrombosis.
timeFrame: 30 days
measure: Number of Participants With Thrombosis.
timeFrame: 12 months
measure: Number of Participants With Hemolysis
timeFrame: 30 days
measure: Number of Participants With Hemolysis
timeFrame: 12 months
measure: Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
timeFrame: 30 days
measure: Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
timeFrame: 12 months
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 30 days
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 12 months
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 24 months
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 3 years
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 4 years
measure: Number of Participants With Mitral Valve Stenosis
timeFrame: 5 years
measure: Mitral Valve Area by Planimetry
timeFrame: At Discharge (≤14 days of index procedure)
measure: Mitral Valve Area by Planimetry
timeFrame: 30 Days
measure: Mitral Valve Area by Planimetry
timeFrame: 12 months
measure: Mitral Valve Area by Planimetry
timeFrame: 24 months
measure: Mitral Valve Area by Planimetry
timeFrame: 3 years
measure: Mitral Valve Area by Planimetry
timeFrame: 4 years
measure: Mitral Valve Area by Planimetry
timeFrame: 5 years
measure: Mitral Valve Area by Planimetry Index
timeFrame: 30 Days
measure: Mitral Valve Area by Planimetry Index
timeFrame: 12 months
measure: Mitral Valve Area by Planimetry Index
timeFrame: 24 months
measure: Mitral Valve Area by Pressure Half-time
timeFrame: At Discharge (≤14 days of index procedure)
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 30 days
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 12 months
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 24 months
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 3 years
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 4 years
measure: Mitral Valve Area by Pressure Half-time
timeFrame: 5 years
measure: Mitral Valve Area by Pressure Half-time Index
timeFrame: 30 Days
measure: Mitral Valve Area by Pressure Half-time Index
timeFrame: 12 months
measure: Mitral Valve Area by Pressure Half-time Index
timeFrame: 24 months
measure: Transvalvular Mitral Valve Gradient
timeFrame: At Discharge (≤ 14 days following index procedure)
measure: Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
timeFrame: 12 months
measure: Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
timeFrame: 24 months
measure: Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
timeFrame: 3 year
measure: Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
timeFrame: 4 year
measure: Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
timeFrame: 5 years
measure: Post-procedure Length of Hospital Stay
timeFrame: 30 Days
measure: Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
timeFrame: 30 Days
measure: Number of Participants With Hospital Re-admissions
timeFrame: 30 days
measure: Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
timeFrame: 30 Days
measure: Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
timeFrame: 30 days
measure: Number of Participants With New Coumadin (Warfarin) Usage
timeFrame: 30 days
measure: Number of Participants With New Coumadin (Warfarin) Usage
timeFrame: 12 months
measure: Number of Participants With Durability of the MitraClip Device and Surgery.
timeFrame: 12 months
measure: Number of Participants With Durability of the MitraClip Device and Surgery.
timeFrame: 12-18 months
measure: Number of Participants With Durability of the MitraClip Device and Surgery.
timeFrame: 18-24 months
measure: Number of Participants With Durability of the MitraClip Device and Surgery.
timeFrame: 24 months-3 year
measure: Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
timeFrame: 12 months
measure: Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
timeFrame: 24 months
measure: Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
timeFrame: 3 years
measure: Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
timeFrame: 12 months
measure: Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
timeFrame: 24 months
measure: Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
timeFrame: 3 years
measure: Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
timeFrame: 4 years
measure: Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
timeFrame: 5 years
measure: Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
timeFrame: 12 months
measure: Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
timeFrame: 24 months
measure: Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
timeFrame: 3 years
measure: Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
timeFrame: 4 years
measure: Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
timeFrame: 5 years
measure: Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
timeFrame: 12 months
measure: Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
timeFrame: 12 months to 3 years
measure: Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
timeFrame: 12 months to 4 years
measure: Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
timeFrame: 12 months to 5 years
measure: Number of Participants With Non-cerebral Thromboembolism.
timeFrame: 12 months
measure: Number of Participants With MR Severity
timeFrame: 30 days
measure: Number of Participants With MR Severity
timeFrame: 12 months
measure: Number of Participants With MR Severity
timeFrame: 24 months
measure: Number of Participants With MR Severity
timeFrame: 3 years
measure: Number of Participants With MR Severity
timeFrame: 4 years
measure: Number of Participants With MR Severity
timeFrame: 5 years
measure: Number of Participants With Non-cerebral Thromboembolism.
timeFrame: 30 days
measure: Number of Participants With Incidence of Mitral Valve Replacement
timeFrame: 12 months
measure: Number of Participants With Incidence of Mitral Valve Replacement
timeFrame: 24 months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Ted Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center, Department of Surgery
name: Donald G Glower Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
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