Paired-Ring Mitral Annuloplasty Ring Sizing Device
ConditionHeart Valve Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndeavor Health
About this trial
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients scheduled for mitral repair surgery
Age 18 years or older
Disqualifiers
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
Trial population
Patients undergoing mitral valve repair.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Annuloplasy ring sizing device
DeviceA 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).
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Annuloplasty ring sizing tool1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov