Paired-Ring Mitral Annuloplasty Sizing Device for Mitral Valve Repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This was a pilot feasibility study of an investigational, temporary sizing device used during mitral valve repair surgery to directly measure the mitral valve opening and guide final ring size. The aim is to determine whether the paired-ring sizing system can provide a more precise size selection than current rough methods. Enrollment includes adults scheduled for mitral repair, with standard exclusions such as inability to consent or conditions requiring replacement instead. The study is conducted at Endeavor Health in Glenview, Illinois, with Endeavor Health as the lead sponsor. Interventions involve using the annuloplasty ring sizing device during surgery to inform final ring selection.

Why it matters

Who can join: the full rules

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

Where it's running

• Endeavor Health
  Glenview, Illinois, United States Recruiting

Study contacts

• Principal investigator: Nikola Dobrilovic, MD — Endeavor Health
• Study coordinator: Nikola Dobrilovic, MD
• Email: nikola.dobrilovic@endeavorhealth.org
• Phone: (847) 570-2868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.