Multicenter International Trial Ring AnnulopLasty

Not Applicable

Completed

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: mitral valve repair (SJM® Rigid Saddle Ring)

• Registration Number: NCT00727012
• Lead Sponsor: Abbott Medical Devices

Brief Summary

This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
• Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
• Patients are at least 18 years old.

Exclusion Criteria

• Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
• Patient is pregnant or nursing;
• Patient has active endocarditis;
• Patient is actively participating in another study of an investigational drug or device;
• Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
• Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
• Patients with a major non-cardiac evolving disease;
• Patients with a life expectancy less than 1 year;
• Patients are known to be noncompliant or are unlikely to complete the study;
• Any case in which mitral annuloplasty rings are not indicated;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SJM® Rigid Saddle Ring	mitral valve repair (SJM® Rigid Saddle Ring)	The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.

Primary Outcome Measures

Name	Time	Method
NYHA class	6 months
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).	6 months

Secondary Outcome Measures

Name	Time	Method
adverse events rates	6 months

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Germany