RecruitingNot ApplicableNCT03692598

Study of Transcatheter Tricuspid Annular Repair

Sponsor

Micro Interventional Devices

Enrollment

60 participants

Start Date

Dec 1, 2016

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

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 Criteria21

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

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Interventions

DEVICEMIA, Minimally Invasive Annuloplasty Device - Surgical

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

DEVICEMIA, Minimally Invasive Annuloplasty Device - Percutaneous

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