Status:
COMPLETED
MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study
Lead Sponsor:
Mitralix
Conditions:
Tricuspid Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed 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). ...
Eligibility Criteria
Inclusion
- 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
- Subject has TR of grade 3+ or more
- 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
- Tricuspid Stenosis \>mild
- Tricuspid Subvalvular calcification or calcification of the chordae.
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
- Subject has a history of a myocardial infarction (MI) in the past 3 months
- Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 7 days of the index procedure
- Subject has a history of, or has active endocarditis
- Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits
- Subject is in acute pulmonary edema.
- Subject has hemodynamic instability requiring inotropic or mechanical support.
- Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication
- Subject has renal insufficiency as evidenced by a serum Creatinine \> 3.0mg/dL.
- Subject has ongoing infection or sepsis
- Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy)
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months prior to the index procedure
- Subject requires emergency surgery for any reason
- Subject has a known allergy to Nitinol alloys, 316L\\304 stainless steel.
- Pregnant or lactating women.
- Patients being dependent upon the sponsor or upon the investigator or upon the investigational site.
- Subject has a known contrast media allergy
- Presence of high degree atrio-ventricular block (2nd or 3rd degree A-V block), or the presence of tri-fascicular block
- According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure) and has a life expectancy of less than 1 year.
- Contraindication for treatment with dual antiplatelet therapy for at least 3 months
- Contraindication for TEE including trans-gastric views.
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04071652
Start Date
August 8 2017
End Date
February 28 2023
Last Update
October 19 2023
Active Locations (3)
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1
Haddassah
Jerusalem, Kiryat Hadassah, Israel, 91120
2
The Chain Sheba Medical Center at Tel HaShomer
Ramat Gan, Israel, 52621
3
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906