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NCT06965725Recruiting

Paired-Ring Mitral Annuloplasty Ring Sizing Device

Endeavor Health

Start Date

7/3/2025

Completion Date

11/1/2026

Summary

The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.

Detailed Description

This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. This device enables the direct measurement of the mitral valve opening. Currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. The field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. All patients scheduled for mitral repair surgery 2. Age 18 years or older Exclusion Criteria: 1. Adults unable to consent, 2. Pregnant women and prisoners. 3. Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded. 4. Presence of acute endocarditis infection during the initial screening process

Interventions

DEVICE

Annuloplasy ring sizing device

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Conditions

Heart Valve Diseases

Locations

Endeavor Health

Glenview, Illinois 60026

United States