NCT06965725

Paired-Ring Mitral Annuloplasty Ring Sizing Device

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-05-11
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States