Mitralign Percutaneous Annuloplasty First in Man (FIM) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Mitral Regurgitation
- Sponsor
- Mitralign, Inc.
- Enrollment
- 35
- Locations
- 5
- Primary Endpoint
- The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.
Detailed Description
The primary objective of this study is to test the ability to safely perform mitral posterior annulus plication with the Mitralign System in eligible patients with chronic functional MR using an endovascular approach. Data obtained from this study, combined with extensive pre-clinical data, will provide important technical and early clinical outcome information that will drive the next phase of clinical investigation and potentially enhance the future design of the Mitralign Percutaneous Annuloplasty System. It is anticipated that the Mitralign System will one day provide physicians with a safe and effective alternative therapy for treating patients who are candidates for mitral valve repair and offer a primary therapy option for patients superior to current treatment modalities. This is a single-arm, multi-center, prospective study designed to test the safety and feasibility of the MPAS to treat patients with chronic, functional MR by performing plication of the posterior mitral annulus. Up to a total of 36 patients with chronic functional mitral regurgitation will be enrolled: 1.) Up to 16 patients (12 patients + 1 roll-in patient per site) will be enrolled in Phase I. Up to thirty-four (34) patients will be enrolled in Phase II (MITRALIGN ADVANTAGE). All patients will be followed for 24 months. Up to 5 sites in Europe and South America will participate. Study procedures include implantation of the MPAS, Trans-Esophogeal Echo, Trans-Thoracic Echo, Blood test, 6-min walk, Quality of Life, Chest X-ray and ECG. Descriptive Statistics will be conducted for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with chronic functional mitral regurgitation.
- •Patient is greater than 18 years old.
- •Documented symptoms of CHF - NYHA II-IV.
- •Left ventricular ejection fraction between 30 and 60 percent.
- •Acceptable candidate for cardiac surgery and/or blood transfusion.
- •Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study- specific tests or procedures are performed.
- •Willing to comply with all specified follow-up evaluations.
- •Mitral regurgitation grade
- •Patient has a mitral plane to apex dimension 5 cm.
- •Structurally normal mitral valve.
Exclusion Criteria
- •Patient with significant organic mitral valve pathology such as myxomatous degeneration, mitral valve prolapse or flail leaflets moderate or severe valve calcifications, ruptured papillary muscles or ruptured chordae tendinae.
- •Previous mitral valve repair or mitral valve replacement.
- •Patient with mitral stenosis.
- •Patient with moderate or severe aortic stenosis and or moderate or severe aortic regurgitation.
- •Patient with endocarditis.
- •MI within 30 days prior to the index procedure.
- •Unstable angina.
- •Percutaneous Coronary Intervention within 30 days prior to the index procedure.
- •CABG within 3 months prior to the index procedure.
- •Planned PCI less than 30 days post index procedure.
Outcomes
Primary Outcomes
The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
Time Frame: 30 Days post implant
The primary study endpoint will assess acute safety using a composite clinical endpoint of device-related net adverse cardiac events (NACE) at 30 days. The components of NACE are defined as the occurrence of device related mortality, myocardial infarction, cardiac tamponade, cardiac surgery or stroke in per protocol population
Secondary Outcomes
- Echocardiographic measures(6 Months)