Paired-Ring Mitral Annuloplasty Ring Sizing Device

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06965725

Enrollment

Registered

2025-05-11

Start date

2025-07-03

Completion date

2026-11-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

Annuloplasty Ring, Sizing methods

Brief summary

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

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.

Interventions

DEVICEAnnuloplasy 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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mitral leaflet coaptation length.	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.
Post-procedure, echocardiography measurements - mitral coaptation length.	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).

Countries

United States

Contacts

CONTACTNikola Dobrilovic, MD

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

PRINCIPAL_INVESTIGATORNikola Dobrilovic, MD

Endeavor Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026