NCT06965725 · Endeavor Health
Paired-Ring Mitral Annuloplasty Ring Sizing Device
What this study is about
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
View original scientific description
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
Interventions
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).
Primary outcome measures
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.
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Glenview, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations