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

Completed

• Conditions: Mitral Regurgitation; Mitral Insufficiency

• Registration Number: NCT04161079
• Lead Sponsor: Medtentia International Ltd Oy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-08
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-13
• Primary Completion: 2020-01-29
• Study Completion: 2020-01-29
• Results First Submitted: 2020-05-25
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)	from 2-year follow-up data point to more than 5 years post-procedure	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
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

Secondary Outcome Measures

Name	Time	Method
Safety: All-Cause Mortality	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure	Collected retrospectively
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	day of study visit	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
Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure	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)
Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure	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.
Performance: Number of Subjects With Recurrence of Mitral Regurgitation	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure	Recurrence of mitral regurgitation is defined as changing of mitral regurgitation to moderate or severe according to ACC/AHA classification determined by TTE
Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure	Change from the clinical investigation 2010-040 2-year follow-up in the coaptation height, as measured by TTE

Trial Locations

Locations (1)

Mehiläinen hospital; 🇫🇮 Helsinki, Finland