Minimally invasive treatment for tricuspid regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Semmelweis University, Heart and Vascular Center
  Budapest, Hungary Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• Compare leadless and left bundle branch pacemakers for heart and valve function

  This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.

  Recruiting Guy's and St Thomas' NHS Foundation Trust · London · NCT07534917

• TriClip for treating tricuspid regurgitation in Japan

  This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.

  Recruiting Abbott Medical Devices · Suita, Osaka · NCT07509658

• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

  This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.

  Recruiting Robert Bosch Medical Center · Stuttgart · NCT07464106

• TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation

  This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.

  Recruiting Cardiovalve Ltd. · Bonn · NCT07334691

• Pivot Extend device to treat severe tricuspid regurgitation

  This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.

  Recruiting Tau-MEDICAL Co., Ltd. · Macquarie Park, New South Wales · NCT07172477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.