Tricuspid Regurgitation
Conditions
Brief 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.
Detailed 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.
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
Sponsors
Micro Interventional Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 30 days | 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 |
| Reduction in tricuspid regurgitation at 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) | 3 months | 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. |
| Reduction in tricuspid regurgitation | 3 months | Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline. |
| Quality of Life Measurement | 3 months | Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months |
Countries
Denmark, Hungary, Latvia, Lithuania, Poland
Contacts
Primary ContactAngie Swenson
Outcome results
None listed