Multicenter International Trial Ring AnnulopLasty (MITRAL)

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Device: mitral valve repair (SJM® Rigid Saddle Ring)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: mitral valve repair (SJM® Rigid Saddle Ring); mitral valve repair due to mitral degenerative or functional disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
adverse events rates	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Raffaele De Simone, Prof. Dr., Heidelberg University

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 31, 2008
• First Posted (Estimate): August 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cardiac surgery; mitral valve; heart valve; valve disorder; valve disease; valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CS06003RG