Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

Launched by MITRALIX · Mar 13, 2023

Keywords

ClinConnect Summary

The Mistral study is testing a new device designed to help patients with a condition called tricuspid valve regurgitation (TR), where the heart's tricuspid valve doesn’t close properly, causing blood to flow backward. This trial is specifically for people who are at high risk for traditional heart surgery and need a less invasive option. Eligible participants must be at least 18 years old, have moderate to severe TR, and have a certain level of heart function. They should also be willing to follow the study guidelines and attend follow-up appointments.

If you join this study, you will receive treatment with the Mistral device, which will be done using a small tube inserted through a blood vessel. The trial is currently recruiting participants, and the study team will monitor your health closely throughout the process. It's important to note that if you join, you won't be able to participate in other clinical trials for six months after the procedure. This study aims to determine how effective and safe the Mistral device is for people like you who need help with their heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
• • Subject is ≥ 18 years of age or legal age in host country
• * Minimum of moderate functional or degenerative tricuspid regurgitation:
• • Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion.
• • Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion
• • Subject has left ventricular ejection fraction (LVEF) \>20 %
• • The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
• • Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible.
• • Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure.
• • As determined by the center heart team, the Mistral is the suitable treatment option.
• Exclusion Criteria:
• • Tricuspid Stenosis \>mild
• • Tricuspid Sub valvular calcification or calcification of the chordae.
• • Subjects with Mitral valve severe stenosis and/or severe regurgitation.
• • Previous tricuspid valve repair or replacement that would interfere with placement of Mistral
• • Subjects with severe, uncontrolled hypertension.
• • Subjects, which need to undergo an emergency surgery.
• • Subject is currently participating in another clinical trial that has not yet completed its primary endpoints.
• • Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 30 days.
• • Subject has a history of a myocardial infarction (MI) in the past 30 days.
• • Subject has had a percutaneous coronary intervention (PCI), within the last 30 days before procedure.
• • Subject with active endocarditis.
• • Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits.
• • Subject has hemodynamic instability requiring inotropic or mechanical support.
• • Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication.
• • Subject is on chronic dialysis.
• • Bleeding disorders or hypercoagulable state.
• • In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
• • Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
• • 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.
• • 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).
• • Contraindication for TEE (transesophageal echocardiography) including trans-gastric views.
• • Life expectancy of less than 1 year