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NCT Number: NCT06965725

Paired-Ring Mitral Annuloplasty Ring Sizing Device

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

Recruiting

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endeavor Health

Glenview, Illinois, 60026, United States

Location status: Recruiting

Location contact

Nikola Dobrilovic, MD

CONTACT

[email protected]

847-570-2868

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nikola Dobrilovic, MD

CONTACT

[email protected]

(847) 570-2868

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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