Multicenter International Trial Ring AnnulopLasty

Mitral Valve Insufficiency Clinical Trial

— MITRAL  

Official title:

Multicenter International Trial Ring AnnulopLasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727012
• Other study ID #: CS06003RG
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• mitral valve repair (SJM® Rigid Saddle Ring)
mitral valve repair due to mitral degenerative or functional disease

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	NYHA class		6 months
Secondary	adverse events rates		6 months