Paired-Ring Mitral Annuloplasty Ring Sizing Device

NCT06965725 | Active Not Recruiting DMC

• 1 other identifier: EH23-243
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Valve Diseases

Keywords

Annuloplasty Ring; Sizing methods

Outcome Measures

Primary Outcomes (2)

• Mitral leaflet coaptation length.

  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.

  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.

Study Arms (1)

Annuloplasty ring sizing tool

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

Device: Annuloplasy ring sizing device

Interventions

Annuloplasy ring sizing device 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).

Annuloplasty ring sizing tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing mitral valve repair.

You may qualify if:

• All patients scheduled for mitral repair surgery
• Age 18 years or older

You may not qualify if:

• Adults unable to consent,
• Pregnant women and prisoners.
• Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded.
• Presence of acute endocarditis infection during the initial screening process

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Glenview, Illinois, 60026, United States

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nikola Dobrilovic, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 11, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)