Multicenter International Trial Ring AnnulopLasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00727012

Acronym

MITRAL

Enrollment

180

Registered

2008-08-01

Start date

2008-06-30

Completion date

2010-11-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Insufficiency

Keywords

mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery

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.

Interventions

DEVICEmitral valve repair (SJM® Rigid Saddle Ring)

mitral valve repair due to mitral degenerative or functional disease

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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
NYHA class	6 months

Secondary

Measure	Time frame
adverse events rates	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026