5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults

Study Overview
=================
Brief Summary
-----------------
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016.

Official Title
-----------------
Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040

Conditions
-----------------
Mitral Regurgitation, Mitral Insufficiency

Intervention / Treatment
-----------------
* Device: Medtentia Annuloplasty Ring (MAR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form. Subject had a successful MAR implantation in clinical investigation 2010-040. Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan. Exclusion Criteria: Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MAR population<br>Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 | Device: Medtentia Annuloplasty Ring (MAR)<br>* Mitral valve repair using the MAR performed in clinical investigation 2010-040<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: the Occurrence, Nature and Frequency of Significant Medical Events |  | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | Success will be defined as no change or any improvement in MR class as described in the American College of Cardiology/ American Heart Association (ACC/AHA) Guidelines | from 2-year follow-up data point to more than 5 years post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: All-Cause Mortality | Collected retrospectively | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies |  | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Safety: Number of Cardiovascular Admissions |  | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Safety: the Number of Subjects With Clinically Significant Abnormal Findings | The number of subjects with clinically significant abnormal findings in TTE, electrocardiography (ECG), or vital signs and type of abnormal findings will be listed and tabulated | day of study visit | 
| Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | Change from the clinical investigation 2010-040 2-year follow-up in the following MR parameters, as measured by TTE: - Left ventricle reverse remodeling: left ventricular inner dimension systole and diastole (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole) | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Defined as assessment of NYHA functional class status at clinical Investigation 2010-040 2-year follow-up visit and at this investigation visit more than 5 years post-procedure Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Performance: Number of Subjects With Recurrence of Mitral Regurgitation | Recurrence of mitral regurgitation is defined as changing of mitral regurgitation to moderate or severe according to ACC/AHA classification determined by TTE | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 
| Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE | Change from the clinical investigation 2010-040 2-year follow-up in the coaptation height, as measured by TTE | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitral valve, Mitral surgery, Mitral repair, Mitral annuloplasty, Mitral valve surgery, Mitral valve repair, Mitral valve annuloplasty