Paired-Ring Mitral Annuloplasty Ring Sizing Device

July 12, 2025 updated by: Nikola Dobrilovic, Endeavor Health

Evaluation of a Novel Paired-Ring Mitral Annuloplasty Sizing Method and Device

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Endeavor Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing mitral valve repair.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Annuloplasty ring sizing tool
A single time use of a novel sizing tool for mitral valve repair surgery
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitral leaflet coaptation length.
Time Frame: During surgery, immediately prior to prosthesis implantation.
Direct measurement of mitral leaflet coaptation length performed with the sizer in position, performed in mm using surgical (disposable) ruler.
During surgery, immediately prior to prosthesis implantation.
Post-procedure, echocardiography measurements - mitral coaptation length.
Time Frame: After separation from cardiopulmonary bypass.
Indirect measurement of mitral leaflet coaptation length (mm), using standard intraoperative trans-esophageal echocardiography (TEE) images (measurements performed postoperatively based on archived images).
After separation from cardiopulmonary bypass.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Investigators

  • Principal Investigator: Nikola Dobrilovic, MD, Endeavor Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH23-243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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