A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorReValve Solutions Inc.
About this trial
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Eligibility criteria
Qualifiers
Symptomatic MR (≥3+) 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 magnetic resonance imaging (MRI)).
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
Treatments tested in this trial
- ReValve System
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov