The MitraClip System ANZ Clinical Trial is a prospective single arm clinical trial for men and women with significant, chronic mitral regurgitation to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System for treating mitral regurgitatio

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000020785
• Lead Sponsor: Evalve, Inc. A subsidiary of Abbott Vascular Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Age 18 years or older.
2.Significant, chronic MR (greater than or equal to 3+) by echocardiography.
3.In the judgment of the Investigator, transseptal catheterization and femoral vein access are feasible.
4.In the judgment of the Investigator, placement of the MitraClip device on the mitral leaflets is feasible.
5.Mitral valve orifice area greater than or equal to 4.0 cm2.
6.The patient or the patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institution’s Human Research Ethics Committee (HREC) of the respective clinical site.
7.The patient agrees to return for all required post-procedure follow-up visits.

Exclusion Criteria

1.Have need for emergency surgery for any reason or need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid disease.
2.Have undergone prior mitral valve repair surgery or have any currently implanted mechanical prosthetic valve or currently implanted ventricular assist device (VAD).
3.Have active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e., noncompliant, perforated).
4.Transesophageal echocardiography (TEE) is contraindicated.
5.Has a known hypersensitivity or contraindication to trial or procedure medications which cannot be adequately managed medically.
6.Currently participating in an investigational drug trial or another device trial that has not yet completed the primary endpoint or that otherwise clinically interferes with the MitraClip System ANZ Clinical Trial data collection. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
7.Pregnant or planning pregnancy within next 12 months.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiographic Endpoint: MR Severity Grade<br> [at 12 months after implant procedure];Echocardiographic Endpoint: Regurgitant Volume<br>[at 12 months after implant procedure];Echocardiographic Endpoint: Left Ventricle End Diastolic Volume (LVEDV)[at 12 months after implant procedure]