Feasibility Study of the Tioga TMVR System
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTioga Cardiovascular, Inc.
About this trial
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Symptomatic, moderate to severe (3+) or severe (4+) MR
NYHA Functional Classification ≥ II
Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)
Disqualifiers
LVEF < 30%
LVEDD > 70 mm
Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, MAC) unsuitable for the Tioga TMVR System
Severe aortic valve stenosis or regurgitation
Trial design
Design model
Single group
Treatments tested in this trial
Tioga TMVR System
DeviceA bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with Symptomatic MR (MR>=3+)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure
Time frame
From index procedure (Day 0) to 30 days post-procedure2
Primary Performance Endpoint
Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab: * Absence of procedural mortality * Successful access, delivery, and retrieval of the device delivery system * Successful deployment and correct positioning of the first intended device * Freedom from emergency surgery or reintervention related to the device or access procedure
Time frame
At completion of index procedure (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov