Back to resultsMulticenter International Trial Ring AnnulopLasty (MITRAL)
Primary Purpose
Mitral Valve Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
mitral valve repair (SJM® Rigid Saddle Ring)
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery
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;
Sites / Locations
- University of Heidelberg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SJM® Rigid Saddle Ring
Arm Description
The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.
Outcomes
Primary Outcome Measures
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
NYHA class
Secondary Outcome Measures
adverse events rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00727012
Brief Title
Multicenter International Trial Ring AnnulopLasty
Acronym
MITRAL
Official Title
Multicenter International Trial Ring AnnulopLasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
Keywords
mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SJM® Rigid Saddle Ring
Arm Type
Other
Arm Description
The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.
Intervention Type
Device
Intervention Name(s)
mitral valve repair (SJM® Rigid Saddle Ring)
Intervention Description
mitral valve repair due to mitral degenerative or functional disease
Primary Outcome Measure Information:
Title
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
Time Frame
6 months
Title
NYHA class
Time Frame
6 months
Secondary Outcome Measure Information:
Title
adverse events rates
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele De Simone, Prof. Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Multicenter International Trial Ring AnnulopLasty
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