Recruiting

Mitral Annuloplasty

Sponsor:

Endeavor Health

Code:

NCT06965725

Conditions

Heart Valve Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Annuloplasy ring sizing device

Study Details

Brief summary:

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

Conditions

Heart Valve Diseases

Study ID

NCT06965725

Start date

Jul 3, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

22 participants

Anticipated

Interventions and Outcome Measures

Arms

Annuloplasty ring sizing tool

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

Interventions

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).

Primary outcome measure

  • Mitral leaflet coaptation length. [ Time Frame: During surgery, immediately prior to prosthesis implantation. ]
  • Post-procedure, echocardiography measurements - mitral coaptation length. [ Time Frame: After separation from cardiopulmonary bypass. ]

Central Contacts and Locations

Central contacts

Nikola Dobrilovic, MD

(847) 570-2868nikola.dobrilovic@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Nikola Dobrilovic, MD

847-570-2868nikola.dobrilovic@endeavorhealth.org

More Information

Sponsor

Endeavor Health

Last update posted

Sep 4, 2026

Last verified

Jul, 2026

Keywords

  • Annuloplasty Ring
  • Sizing methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-09-04.