Feasibility Study of a Percutaneous Mitral Valve Repair System.

Phase 1

Completed

Conditions: Mitral Valve Regurgitation
Mitral Valve Insufficiency
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency

Interventions: Device: Percutaneous mitral valve repair (MitraClip Implant)

Registration Number: NCT00209339

Lead Sponsor: Abbott Medical Devices

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MitraClip	Percutaneous mitral valve repair (MitraClip Implant)	Percutaneous mitral valve repair (MitraClip Implant)

Primary Outcome Measures

Name	Time	Method
Mitral Regurgitation Severity	At 5 years	All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Major Adverse Events (MAE)	Through 6 Months	Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.

Secondary Outcome Measures

Name	Time	Method
Number of Mitraclip Devices Implanted	At day 0 (on the day of index procedure)
Second Intervention to Place a Second MitraClip Device	Post index procedure through 5 years
MitraClip Device Embolizations and Single Leaflet Device Attachment	Post index procedure through 5 years	MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.
Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)	At 5 Years	Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.
Death (Kaplan-Meier Freedom From Death)	At 5 years
Major Vascular and Bleeding Complications	Through 6 Months	Major bleeding complications is defined as transfusion of \>=2 units of blood due to bleeding related to the index procedure
Procedure Time	At day 0 (on the day of index procedure)	Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours. The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device.
Cardiac Output	60 months	Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Device Time	At day 0 (on the day of index procedure)	Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.
Fluoroscopy Duration	At day 0 (on the day of index procedure)	Mean fluoroscopy duration during the MitraClip procedure.
Contrast Volume	At day 0 (on the day of index procedure)	Mean contrast volume utilized during the MitraClip procedure.
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration	Post index procedure within 30 days
Post-procedure Hospital Stay	Post-index procedure until hospital discharge (1 to 19 days)
Left Ventricular End Diastolic Volume	60 months	Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume	60 months	Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Intra-procedural Major Adverse Events	At day 0 (on the day of index procedure)	Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure
Other Secondary Safety Events	Through 6 months	Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Mitral Valve Gradient	60 months	Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
New York Heart Association (NYHA) Functional Class	60 months	Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Mitral Valve Area - Single Orifice	60 months	Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.
Mitral Valve Area (MVA) by Pressure Half-Time	60 months	The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm\^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography.
Cardiac Index	60 months	Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.