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

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

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 Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Mitral Insufficiency
• Intervention / Treatment: Device: Medtentia Annuloplasty Ring (MAR)

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00260
    • Mehiläinen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects, who underwent mitral valve repair operation with successful MAR implantation in clinical investigation 2010-040.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MAR population; Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040	Device: Medtentia Annuloplasty Ring (MAR); Mitral valve repair using the MAR performed in clinical investigation 2010-040

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction		since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Quality of Life Scores as Measured by the 15D© Questionnaire	15D© questionnaire investigates the standard of quality of life (QOL15D) through a general health assessment and not specific to a particular disease or age. It is a 15-domain (mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality and sexual activity) questionnaire. Each domain score ranges from 1 (no problems) to 5 (extreme problems), with lower scores reflecting better health-related functional status.	day of study visit

Collaborators and Investigators

• Sponsor: Medtentia International Ltd Oy
• Investigators: Principal Investigator: Tapio Aalto, MD, Mehiläinen hospital

Publications and helpful links

Helpful Links

• Medtentia Company Webpage

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): January 29, 2020
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mitral valve; Mitral surgery; Mitral repair; Mitral annuloplasty; Mitral valve surgery; Mitral valve repair; Mitral valve annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2010-040FU5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No