Replacement of the Native Mitral Valve Using the ReValve System
ConditionMitral Valve Replacement
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorReValve Solutions Inc.
About this trial
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic functional and/or degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.
New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac CT.
Age greater than 18 years.
Disqualifiers
Untreated clinically significant coronary artery disease requiring revascularization.
Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
Status 1 heart transplant or prior orthotopic heart transplantation.
Cerebrovascular accident within 30 days prior to subject's consent.
Trial design
Design model
Single group
Treatments tested in this trial
ReValve System
DeviceMitral Valve Replacement Device
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Single Arm StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Technical Success
The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system
Time frame
ProcedureSponsors and contacts
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Source ClinicalTrials.gov