Study of Transcatheter Tricuspid Annular Repair (STTAR)

Micro Interventional Devices

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Device: MIA, Minimally Invasive Annuloplasty Device - Surgical; Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous

Study type: Interventional

Funder types: Industry

Identifiers

NCT03692598

MID-002

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Full description

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MIA Surgical

Experimental group

Description:

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach

Treatment:

Device: MIA, Minimally Invasive Annuloplasty Device - Surgical

MIA Percutaneous

Experimental group

Description:

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach

Treatment:

Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous