Paired-Ring Mitral Annuloplasty Ring Sizing Device

NCT ID: NCT06965725

Last Updated: 2025-07-15

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-03

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Valve Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Annuloplasty ring sizing tool

A single time use of a novel sizing tool for mitral valve repair surgery

Annuloplasy ring sizing device

Intervention Type DEVICE

A single time use of a novel sizing tool for mitral valve repair surgery (used ONLY in an observational capacity - this device does NOT influence decision-making during the conduct of the operation in any way).

Interventions

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Annuloplasy ring sizing device

A single time use of a novel sizing tool for mitral valve repair surgery (used ONLY in an observational capacity - this device does NOT influence decision-making during the conduct of the operation in any way).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Nikola Dobrilovic

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikola Dobrilovic, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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Endeavor Health

Glenview, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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EH23-243

Identifier Type: -

Identifier Source: org_study_id

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