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

Medtentia International Ltd Oy12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mitral Regurgitation Mitral Insufficiency

Interventions

Medtentia Annuloplasty Ring (MAR)DEVICE

Mitral valve repair using the MAR performed in clinical investigation 2010-040

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mehiläinen hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Safety: the Occurrence, Nature and Frequency of Significant Medical Events

Time frame: 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

Time frame: from 2-year follow-up data point to more than 5 years post-procedure

Secondary Outcomes

Safety: All-Cause Mortality

Collected retrospectively

Time frame: 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

Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure

Safety: Number of Cardiovascular Admissions

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure