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

Sponsors

Lead Sponsor: Medtentia International Ltd Oy

Source 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.

Overall Status Completed
Start Date 2019-11-08
Completion Date 2020-01-29
Primary Completion Date 2020-01-29
Study Type Observational
Primary Outcome
Measure 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) from 2-year follow-up data point to more than 5 years post-procedure
Secondary Outcome
Measure Time Frame
Safety: All-Cause Mortality 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 day of study visit
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
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
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
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
Enrollment 12
Condition
Intervention

Intervention Type: Device

Intervention Name: Medtentia Annuloplasty Ring (MAR)

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

Arm Group Label: MAR population

Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Tapio Aalto, MD Principal Investigator Mehiläinen hospital
Location
Facility: Mehiläinen hospital
Location Countries

Finland

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: MAR population

Description: Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

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