Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2016-12-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MIA Surgical
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach
MIA, 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
MIA Percutaneous
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach
MIA, 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
Interventions
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MIA, 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
MIA, 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Micro Interventional Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Kestutis Rucinskas, MD
Role: PRINCIPAL_INVESTIGATOR
Vilnius University Hospital, Santariskiu Klinikos
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Semmelweis University, Heart and Vascular Center
Budapest, , Hungary
Centre of Cardiology, Pauls Stradins Clinical University Hospital
Riga, , Latvia
Lithuanian University of Health Sciences
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Steen H Poulsen
Role: primary
Bela Merkely
Role: primary
Andrejs Erglis
Role: primary
Rimantas Benetis
Role: primary
Marcin Demkow
Role: primary
Other Identifiers
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MID-002
Identifier Type: -
Identifier Source: org_study_id
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