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The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Full description
The study is designed to clinically demonstrate device acute safety and technical performance (Primary Endpoints) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).
The main objectives of the study are:
Primary endpoints:
Secondary endpoints:
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Inclusion criteria
Subject has given signed study Informed Consent for participation prior to procedure.
Subject is ≥ 18 years of age or legal age in host country
Subject is willing and able to comply with all required follow-up evaluations
Genders eligible for the study: Both genders
Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
o Subjects with moderate TR: Only NYHA Class III or IV maybe considered for inclusion.
Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion Subject has left ventricular ejection fraction (LVEF) >20 %
Subject is of functional class 2 or more (NYHA)
The subject is high risk to undergo TV surgery as assessed and consented by a cardiac surgeon and an interventional cardiologist at the site (center heart team), and according to ESC/EACTS guidelines on the management of valvular heart disease.
Patients with Jugular and/or Femoral veins enabling catheterization with 12Fr catheters
Life expectancy ≥ 1 year
Exclusion criteria
Primary purpose
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Interventional model
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9 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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