Phase 2
Completed N=55
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Mitral Valve Insufficiency · Mitral Valve Regurgitation · Mitral Valve Incompetence · Mitral Regurgitation
Source: ClinicalTrials.gov NCT00209339 ↗
Enrolled (actual)
55
Serious AEs
65.5%
Results posted
Aug 2016
Primary outcomePrimary: Mitral Regurgitation Severity — 0.0; 0.0; 5.6; 38.9 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mitral Regurgitation Severity |
0.0; 26.7; 46.7; 26.7; 0.0 | — |
| PRIMARY Major Adverse Events (MAE) |
1.8; 1.8; 1.8; 1.8; 7.2; 3.6 | — |
| SECONDARY Procedure Time |
254.7 | — |
| SECONDARY Device Time |
198.5 | — |
| SECONDARY Contrast Volume |
112.0 | — |
| SECONDARY Fluoroscopy Duration |
59.8 | — |
| SECONDARY Number of Mitraclip Devices Implanted |
10.9; 61.8; 27.3 | — |
| SECONDARY Intra-procedural Major Adverse Events |
0.0; 0.0; 1.8; 0.0; 0.0; 1.8 | — |
| SECONDARY Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration |
56.7 | — |
| SECONDARY Post-procedure Hospital Stay |
2.9 | — |
| SECONDARY Second Intervention to Place a Second MitraClip Device |
2 | — |
| SECONDARY MitraClip Device Embolizations and Single Leaflet Device Attachment |
0; 5 | — |
| SECONDARY Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) |
55.1 | — |
| SECONDARY Death (Kaplan-Meier Freedom From Death) |
86.4 | — |
| SECONDARY Major Vascular and Bleeding Complications |
7.3; 5.5; 0.0 | — |
| SECONDARY Other Secondary Safety Events |
1.8; 0.0; 0.0; 3.6 | — |
| SECONDARY Left Ventricular End Diastolic Volume |
107.0 | — |
| SECONDARY Left Ventricular End Systolic Volume |
40.4 | — |
| SECONDARY Mitral Valve Area - Single Orifice |
3.3 | — |
| SECONDARY Mitral Valve Area (MVA) by Pressure Half-Time |
2.8 | — |
| SECONDARY Mitral Valve Gradient |
3.6 | — |
| SECONDARY Cardiac Output |
3.7 | — |
| SECONDARY Cardiac Index |
2.1 | — |
| SECONDARY New York Heart Association (NYHA) Functional Class |
5; 9; 1; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00209339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.