Study of Transcatheter Tricuspid Annular Repair

Launched by MICRO INTERVENTIONAL DEVICES · Sep 28, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the MIA Minimally Invasive Annuloplasty Device, designed to help patients with a heart condition known as chronic functional tricuspid regurgitation. This condition means that the heart's tricuspid valve doesn't close properly, which can lead to blood flowing backward in the heart. The study aims to see how safe and effective this device is for patients who are undergoing heart surgery and have moderate to severe issues with this valve.

To participate, patients generally need to be between 18 and 85 years old and have a specific level of tricuspid regurgitation. They should be experiencing symptoms that affect their daily activities, and their heart function should be at a certain level. However, there are several reasons someone might not be eligible, such as having uncontrolled high blood pressure, a recent heart attack, or certain other serious health conditions. If eligible, participants can expect to undergo the procedure as part of their heart surgery and will be monitored closely to assess how well the device works and to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
• • 2. Age≥18 and ≤85 years old
• • 3. New York Heart Association (NYHA) Class II, III or ambulatory IV
• • 4. Left ventricular ejection fraction (LVEF) ≥30%
• • 5. Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
• • 6. Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR
• • 7. Patient provides written Informed Consent before any study-specific tests or procedures are performed
• • 8. Patient is willing and able to comply with all specified study evaluations
• Exclusion Criteria:
• • 1. Pregnant or lactating female
• • 2. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
• • 3. Previous tricuspid valve repair or replacement
• • 4. Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
• • 5. Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
• • 6. Life expectancy of less than 12-months
• • 7. Severe right heart dysfunction
• • 8. Pulmonary hypertension with PA mean 2/3 rd MAP
• • 9. Active systemic infection
• • 10. Pericardial infection
• • 11. Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
• • 12. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression)
• • 13. Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
• • 14. Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
• • 15. Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
• • 16. Cerebrovascular event within the past 6 months
• • 17. History of mitral/tricuspid endocarditis within the last 12 months
• • 18. Organic tricuspid disease
• • 19. Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
• • 20. Known alcohol or drug abuser
• • 21. Currently participating in the study of an investigational drug or device