Minimally invasive treatment for tricuspid regurgitation
Study of Transcatheter Tricuspid Annular Repair
This study is testing a new device to see if it can safely help people with a leaky heart valve feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Micro Interventional Devices Industry-sponsored |
| Locations | 6 sites (Aarhus and 5 other locations) |
| Trial ID | NCT03692598 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients suffering from chronic functional tricuspid regurgitation. It is a prospective, multi-center study where participants will undergo clinical assessments at 1 month, 6 months, and 1 year following the implant procedure. The study aims to determine the effectiveness of this device in improving patient outcomes related to heart function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with moderate to severe chronic functional tricuspid regurgitation who are undergoing cardiac surgery.
Not a fit: Patients with severe uncontrolled hypertension, previous tricuspid valve repairs, or recent myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with tricuspid regurgitation.
How similar studies have performed: Other studies have shown promise with similar minimally invasive approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aarhus and 5 other locations
- Aarhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
- Semmelweis University, Heart and Vascular Center — Budapest, Hungary (Not_yet_recruiting)
- Centre of Cardiology, Pauls Stradins Clinical University Hospital — Riga, Latvia (Recruiting)
- Lithuanian University of Health Sciences — Kaunas, Lithuania (Recruiting)
- Vilnius University Hospital Santariskiu Klinikos — Vilnius, Lithuania (Recruiting)
- The Cardinal Stefan Wyszyński Institute of Cardiology — Warsaw, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Kestutis Rucinskas, MD — Vilnius University Hospital, Santariskiu Klinikos
- Study coordinator: Angie Swenson
- Email: aswenson@microinterventional.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.