TRICUS STUDY - Safety and Efficacy of the TricValve® Device

Study Overview
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Brief Summary
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The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

Detailed Description
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TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy. Pre-Clinical and Clinical preliminary studies have shown an acceptable safety and performance profile of the TricValve® Transcatheter Bicaval Valves System. Given that the medical device is a potential long-term treatment for patients with tricuspid insufficiency, clinical data for long-term treatment periods is necessary. Thus, the current study is designed to investigate the safety and performance for at least 30 days and up to 6 months. The study has been approved by the Kaunas Regional Biomedical Research Ethics Committee.

Official Title
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TRICUS STUDY - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation.

Conditions
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Severe Tricuspid Regurgitation

Intervention / Treatment
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* Device: TricValve® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be 18 years of age or older The subject must be a patient with severe symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the lower (IVC) and/or upper (SVC) vena cava and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and/or SVC 2-4 cm above/ below right atrium (RA) inflow) within 8 weeks prior to the implantation Suitable for TricValve® Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV The subject has left ventricular ejection fraction (LVEF) ≥ 40% Distance covert in 6-minute walk test (6MWT) ≥ 60m The patient shall be screened by a Heart Team - including an interventional cardiologist, cardiothoracic surgeon, and agreed as a candidate for the TricValve® Transcatheter Bicaval Valves System implantation Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of the clinical protocol Exclusion Criteria: Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart teams decision Requirement for other elective cardiac procedures e.g. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) up to 90 days after the procedure or 30 days before the procedure Right ventricular failure (TAPSE ≤13mmHg) Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography Presence of any known life threatening (noncardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year Cerebro-vascular event within the past 3 months History of mitral/tricuspid endocarditis within the last 12 months Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis) Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k) Documented evidence of significant renal dysfunction (serum creatinine > 3.0mg/dl) or on any form of dialysis at time of screening within the last 4 weeks Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately premedicated Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter The patient has contraindication against a transesophageal echo (TEE) during the procedure Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days) Liver cirrhosis Child C (see appendix) Female patient of child-bearing potential Psychiatric or behavioural disease including known alcohol or drug abuser that is likely to impair compliance with protocol Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study Requirement for Antibiotic Treatment within the last 48 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TricValve® System Single-Arm<br>Minimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement | Device: TricValve® System<br>* The TricValve® Delivery System is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is unsheathed at the implantation site and positions itself as per the anatomy - self expanding frame.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with major adverse events | The percentage of participants with major adverse events (death, myocardial infarction, cardiac tamponade, cardiac surgery for failed TricValve® implantation, stroke. Major bleeding according to Valve Academic Research Consortium (VARC) criteria) | 30 days | 
| Change of New York Heart Association (NYHA) functional class | Change of New York Heart Association (NYHA) functional class from III or IV to a lower one | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation | The percentage of surviving participants with successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure. | Up to Discharge (≤ 10 days post index procedure) | 
| Unrestricted movement of cusps | The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal) | Up to 30 days, up to 6 months | 
| Cusp insufficiency | The change of the degree of cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value | Up to 30 days, up to 6 months | 
| Device success | Device success as measured by number of patients who are alive with intended device in place with no additional surgical or interventional procedures related to the TricValve®. | Up to 30 days, up to 6 months | 
| NYHA functional class | Number of Patients with improvement of NYHA functional class | Up to 30 days | 
| 6 Minute Walk Test | Improvement in distance (m) in the 6 Minute Walk Test | Up to 30 days, up to 6 months | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Number of Patients with improvement in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ, a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Range of 0-100, in which higher scores reflect better health status.) | Up to 30 days, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases