Multicenter International Trial Ring AnnulopLasty

NCT ID: NCT00727012

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-11-30

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.

Conditions

Mitral Valve Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

mitral valve repair (SJM® Rigid Saddle Ring)

Intervention Type: DEVICE

mitral valve repair due to mitral degenerative or functional disease

Interventions

mitral valve repair (SJM® Rigid Saddle Ring)

mitral valve repair due to mitral degenerative or functional disease

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

University of Heidelberg

Principal Investigators

Raffaele De Simone, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

University of Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

CS06003RG

Identifier Type: -

Identifier Source: org_study_id