Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring

NCT01987635

Mitral Valve Disease

COMPLETED NA

A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy

NCT03592043

Mitral Regurgitation

COMPLETED

Structural Mitral Valve Project

NCT05678868

Mitral Regurgitation

UNKNOWN

Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation

NCT00807040

Mitral Valve Insufficiency Coronary Artery Disease

COMPLETED PHASE2

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

NCT04161079

Mitral Regurgitation Mitral Insufficiency

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEMO 3D ring

All patients in the study will be implanted with the MEMO 3D ring

Group Type OTHER

Implantation of the MEMO 3D Annuloplasty Ring

Intervention Type DEVICE

Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation of the MEMO 3D Annuloplasty Ring

Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The subject is 18 years old or older
* An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
* The subject is able to return for all follow-up evaluations of the study.

Exclusion Criteria

* The subject or subject's legal representative is unwilling to sign the informed consent.
* The subject is or will be participating in another medical device or drug clinical trial.
* The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
* The subject has a life expectance of less than 1 year.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No