Mitral RegurgitationNCT04161079

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

An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Medtentia International Ltd Oy at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Mitral Regurgitation, Mitral Insufficiency
What is being tested?: Medtentia Annuloplasty Ring (MAR)
Type of treatment: Medical device
How many people: 12 participants
Where: 1 siteFinland
Study dates: 8 Nov 2019to 29 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Mehiläinen hospital
Helsinki, 00260

Other trials in Finland

About this study

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

Conditions: Mitral Regurgitation, Mitral Insufficiency
Being tested: Medtentia Annuloplasty Ring (MAR)
Keywords: Mitral valve, Mitral surgery, Mitral repair, Mitral annuloplasty, Mitral valve surgery, Mitral valve repair, Mitral valve annuloplasty
Medical subject headings: Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04161079
Study group	Role	What they receive
MAR population		Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 Receives: Device: Medtentia Annuloplasty Ring (MAR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: the Occurrence, Nature and Frequency of Significant Medical Events
Measured: 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
Measured: from 2-year follow-up data point to more than 5 years post-procedure

Secondary outcomes (8)

Safety: All-Cause Mortality
Collected retrospectively
Measured: 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
Measured: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Safety: Number of Cardiovascular Admissions
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201929 Jan 2020

First posted13 Nov 2019
Study start8 Nov 2019
Primary completion29 Jan 2020
Study completion29 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04161079
Sponsor's protocol ID: 2010-040FU5
Status last verified: Sep 2020
First submitted: 8 Nov 2019
Last updated: 28 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
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Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
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All Mitral Regurgitation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040
ClinicalTrials.gov ID: NCT04161079
Acronym / sponsor ID: 2010-040FU5
Conditions: Mitral Regurgitation, Mitral Insufficiency
Keywords: Mitral valve, Mitral surgery, Mitral repair, Mitral annuloplasty, Mitral valve surgery, Mitral valve repair, Mitral valve annuloplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Medtentia International Ltd OyIndustry (pharma, biotech, devices)
Study start: 8 Nov 2019 (actual)
Primary completion: 29 Jan 2020 (actual)
Study completion: 29 Jan 2020 (actual)
First posted: 13 Nov 2019 (actual)
Results: Posted 28 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
MAR population	–	Device: Medtentia Annuloplasty Ring (MAR)Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects, who underwent mitral valve repair operation with successful MAR implantation in clinical investigation 2010-040.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtentia Annuloplasty Ring (MAR)Mitral valve repair using the MAR performed in clinical investigation 2010-040	Device	MAR population

Primary outcome

Safety: the Occurrence, Nature and Frequency of Significant Medical Events
Time frame: 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)
Time frame: from 2-year follow-up data point to more than 5 years post-procedure
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

8 secondary outcomes

Safety: All-Cause Mortality
Time frame: 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
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Safety: Number of Cardiovascular Admissions
Time frame: 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
Time frame: day of study visit
Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure

Results and safety

Results posted to the registry on 28 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAR Population	12	11

Primary outcome: Safety: the Occurrence, Nature and Frequency of Significant Medical Events

Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure. Number. Unit: Events

Measure	MAR Population n = 7
Value	0

Primary outcome: Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)

Time frame: from 2-year follow-up data point to more than 5 years post-procedure. Count of participants. Unit: Participants

Measure	Clinical Investigation 2010-040 2-year Follow-up n = 11	2010-040FU5 >5 Years Follow-up n = 7
I - None/Trivial	8	5
II - Mild	3	2
III - Moderate	0	0
IV - Severe	0	0

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinical Investigation 2010-040 2-year Follow-up	0 of 0	0 of 0	1 of 11
2010-040FU5 >5 Years Follow-up	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Medtentia Company WebpageLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Mitral Regurgitation

RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
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Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
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Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
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Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tapio Aalto, MD principal investigator

Mehiläinen hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Medtentia International Ltd Oy at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: the Occurrence, Nature and Frequency of Significant Medical Events (time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04161079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.