Actively Recruiting
Study of Transcatheter Tricuspid Annular Repair
Led by Micro Interventional Devices · Updated on 2024-10-23
60
Participants Needed
6
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Study of Transcatheter Tricuspid Annular Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic functional tricuspid regurgitation with at least moderate severity (2-4)
- Age 18 to 85 years old
- New York Heart Association (NYHA) Class II, III or ambulatory IV
- Left ventricular ejection fraction (LVEF) of 30% or higher
- Undergoing cardiac surgery with planned use of cardiopulmonary bypass (for surgical arm only)
- Functional tricuspid valve regurgitation with structurally normal valve and annular diameter 40 mm or greater (or 21 mm/m2) and 55 mm or less (or 29 mm/m2) or 2-4+ FTR
- Provides written informed consent before study procedures
- Willing and able to comply with all study evaluations
You will not qualify if you...
- Pregnant or lactating female
- Severe uncontrolled hypertension (systolic blood pressure 180 mmHg or higher and/or diastolic blood pressure 110 mmHg or higher)
- Previous tricuspid valve repair or replacement
- Myocardial infarction or unstable angina within 30 days before the procedure
- Percutaneous coronary intervention (PCI) within 30 days before or planned within 3 months after the procedure
- Life expectancy less than 12 months
- Severe right heart dysfunction
- Pulmonary hypertension with pulmonary artery mean pressure two-thirds or more of mean arterial pressure
- Active systemic infection
- Pericardial infection
- Any condition increasing risk with device deployment as judged by investigator
- Co-morbid conditions posing unacceptable surgical risk, such as severe COPD, liver failure, cardiac disease, autoimmune disorders, or severe immunosuppression
- Untreated coronary artery disease requiring revascularization unless CABG is performed with MIA repair (surgical arm only)
- Hemodynamic instability including low systolic blood pressure (<90 mmHg), shock, or need for inotropic medication or intra-aortic balloon pump
- Active peptic ulcer or gastrointestinal bleeding in past 3 months
- Cerebrovascular event in past 6 months
- History of mitral or tricuspid endocarditis within last 12 months
- Organic tricuspid disease
- Allergy or contraindication to device components, aspirin, anticoagulation therapy, or contrast media that cannot be managed
- Known alcohol or drug abuse
- Currently participating in another investigational drug or device study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Aarhus University Hospital
Aarhus, Denmark
Not Yet Recruiting
2
Semmelweis University, Heart and Vascular Center
Budapest, Hungary
Not Yet Recruiting
3
Centre of Cardiology, Pauls Stradins Clinical University Hospital
Riga, Latvia
Actively Recruiting
4
Lithuanian University of Health Sciences
Kaunas, Lithuania, 50009
Actively Recruiting
5
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, 08661
Actively Recruiting
6
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Poland
Not Yet Recruiting
Research Team
A
Angie Swenson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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