Study of Transcatheter Tricuspid Annular Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Transcatheter Tricuspid Annular Repair

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: MIA, Minimally Invasive Annuloplasty Device - Surgical
* Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIA Surgical<br>Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach | Device: MIA, Minimally Invasive Annuloplasty Device - Surgical<br>* Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach<br>* Other names: MIA-S;|
| Experimental: MIA Percutaneous<br>Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach | Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous<br>* Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach<br>* Other names: MIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | The percentage of participants with Major Adverse Events within 30 days of the procedure: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed MIA implantation, or stroke | 30 days | 
| Reduction in tricuspid regurgitation at 30 days | The reduction in the degree of tricuspid regurgitation compared to baseline measured post-procedure, at post-operative hospital discharge and at 1 month post-operative. Ability to reduce tricuspid regurgitation by at least 1 degree by means of quantitative echocardiographic parameters | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) | The percentage of participants with Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) within 6 months of the procedure will be compared to the literature. | 3 months | 
| Reduction in tricuspid regurgitation | Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline. | 3 months | 
| Quality of Life Measurement | Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months | 3 months |