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Recruiting NCT07450911

The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE

Phase I Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ReValve System.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

Overview

An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Interventions

  • Device ReValve System
    Mitral Valve Replacement Device

Primary outcome measures

  • Technical Success [Time frame: Procedure]

Eligibility criteria

Inclusion criteria

  • 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
  • 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.

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 left atrium (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Georgia · 3 centers
  • Healthycore — Tbilisi
  • Tbilisi Heart and Vascular Center — Tbilisi
  • Tiblisi Heart Center — Tbilisi

Identifiers

NCT: NCT07450911 · CIP-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗