An observational study in Heart Valve Diseases, sponsored by Endeavor Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Endeavor Health · Observational
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
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.
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 22 is below the median of 300 across 226 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing mitral valve repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A single time use of a novel sizing tool for mitral valve repair surgery
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).
Mitral leaflet coaptation length.
Direct measurement of mitral leaflet coaptation length performed with the sizer in position, performed in mm using surgical (disposable) ruler.
Time frame: During surgery, immediately prior to prosthesis implantation.
Post-procedure, echocardiography measurements - mitral coaptation length.
Indirect measurement of mitral leaflet coaptation length (mm), using standard intraoperative trans-esophageal echocardiography (TEE) images (measurements performed postoperatively based on archived images).
Time frame: After separation from cardiopulmonary bypass.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Nov 2026, 16 months after the start.
Of 95 non-industry observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's planned 16 months is below that.
Counting every sponsor, half of 115 studies reached it within 67 months; a quarter within 23 and three quarters within 212.
How these figures are worked out, and which studies are left out of them.
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