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

NCT04161079 | Completed Results

• 1 other identifier: 2010-040FU5
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation; Mitral Insufficiency

Keywords

Mitral valve; Mitral surgery; Mitral repair; Mitral annuloplasty; Mitral valve surgery; Mitral valve repair; Mitral valve annuloplasty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Other Outcomes (2)

• 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

  day of study visit

Study Arms (1)

MAR population

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

Device: Medtentia Annuloplasty Ring (MAR)

Interventions

Medtentia Annuloplasty Ring (MAR) DEVICE

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

MAR population

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system.

Sponsors & Collaborators

• Medtentia International Ltd Oy: lead

Study Sites (1)

Mehiläinen hospital

Helsinki, 00260, Finland

Location

Related Links

• Medtentia Company Webpage

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The investigation was limited by its retrospective nature and design. Due to small study sample not all the comparisons of the parameters at the two timepoints (2-year and 5-year follow-up) could be performed.

Results Point of Contact

• Title: Olli Keränen / Chief Executive Officer
• Organization: Medtentia International Ltd Oy

ok@medtentia.com

+358 50 3567090

Study Officials

• Tapio Aalto, MD

  Mehiläinen hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 8, 2019
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: September 28, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)