A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSierra Valve LLC
About this trial
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older(≥ 18 years)
Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.
Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
Feasible transseptal catheterization and femoral vein access.
Disqualifiers
History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
Left ventricular ejection fraction (LVEF)< 20%
Trial design
Design model
Single group
Treatments tested in this trial
GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
DeviceThe GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath. The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Subjects receiving the treatment of GeminiOne TEER systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety: Absence of device or procedure related major adverse events at 30 days
MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure.
Time frame
30 days2
Effectiveness: Acute procedural success (APS)
APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure.
Time frame
30 daysSecondary outcomes
1
All-cause mortality and stroke
Time frame
30 days, 12 months and annually thereafter2
Cardiovascular mortality
Time frame
30 days, 12 months and annually thereafter3
Rate of cardiovascular rehospitalization
Time frame
30 days, 12 months and annually thereafter4
Mitral valve surgery or re-intervention
Time frame
30 days, 12 months and annually thereafterOther outcomes
1
Technical success
Must meet all of the following criteria: 1. No procedural mortality 2. Successful access, delivery, and retrieval of the device delivery system 3. No emergency surgery or reintervention related to the device or access procedure
Time frame
at exit from procedure room2
Device success
Must meet all of the following criteria:\< 1. No procedural mortality 2. Proper delivery and deployment of the device 3. No unplanned surgical or interventional procedures related to the device 4. No specific device-related technical failure or complication 5. Improvement of mitral regurgitation without significant stenosis (MR ≤ 2+), and without associated hemolysis or thrombogenesis
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov