Replacement of the Native Mitral Valve With the ReValve System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study collects preliminary data on the performance and safety of the ReValve System for mitral valve replacement. Eligible participants have symptomatic functional or degenerative MR due to ischemic or non-ischemic cardiomyopathy, are in NYHA class II–IV, and meet echocardiographic criteria. The trial enrolls adults 18 and older and will assess outcomes using multiple cardiac imaging methods and clinical follow-up. Sites are in São Paulo, Brazil, under sponsorship by ReValve Solutions Inc. Primary focus is safety and feasibility of the device in this initial stage.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.
* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.

Key Exclusion Criteria:

* 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.
* Pregnant or planning pregnancy within next 12 months.
* Currently participating in an investigational drug or another device study.
* Evidence of LV or LA thrombus, vegetation or mass
* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.

Where it's running

• Institute Dante Pazzanese of Cardiology - IDPC
  São Paulo, São Paulo, Brazil Recruiting
• The Heart Institute - INCOR
  São Paulo, São Paulo, Brazil Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.