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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161079
• Other study ID #: 2010-040FU5
• Status: Completed
• Start date: November 8, 2019
• Est. completion date: January 29, 2020

Study information

• Verified date: September 2020
• Source: Medtentia International Ltd Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Medtentia Annuloplasty Ring (MAR)
Mitral valve repair using the MAR performed in clinical investigation 2010-040

Locations

Country	Name	City	State
Finland	Mehiläinen hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Medtentia International Ltd Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	Safety: All-Cause Mortality	Collected retrospectively	since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Secondary	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
Secondary	Safety: Number of Cardiovascular Admissions		since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Medtentia Company Webpage