Clinical trial NCT04161079: 5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Official title: Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Mitral Insufficiency
Keywords: Mitral valve
Mitral surgery
Mitral repair
Mitral annuloplasty
Mitral valve surgery
Mitral valve repair
Mitral valve annuloplasty
Lead sponsor: Medtentia International Ltd Oy
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects, who underwent mitral valve repair operation with successful MAR implantation in clinical investigation 2010-040.

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.


Eligibility 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.

Primary outcomes:
measure: Safety: the Occurrence, Nature and Frequency of Significant Medical Events
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
timeFrame: from 2-year follow-up data point to more than 5 years post-procedure
Secondary outcomes:
measure: Safety: All-Cause Mortality
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Safety: Number of Cardiovascular Admissions
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Safety: the Number of Subjects With Clinically Significant Abnormal Findings
timeFrame: day of study visit
measure: Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Performance: Number of Subjects With Recurrence of Mitral Regurgitation
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Other outcomes:
measure: Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction
timeFrame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
measure: Quality of Life Scores as Measured by the 15D© Questionnaire
timeFrame: day of study visit
Locations:
city: Helsinki
country: Finland
facility: Mehiläinen hospital
Study officials:
affiliation: Mehiläinen hospital
name: Tapio Aalto, MD
role: PRINCIPAL_INVESTIGATOR
References: