TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device

Not Applicable

Completed

• Conditions: Severe Tricuspid Regurgitation
• Interventions: Device: TricValve® System

• Registration Number: NCT04141137
• Lead Sponsor: P+F Products + Features GmbH

Brief Summary

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

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 with the aim of CE certification is designed to investigate the safety and performance for at least 30 days and up to 6 months.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2019-12-09
• Primary Completion: 2021-05-05
• Study Completion: 2021-12-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. The subject must be 18 years of age or older
2. 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 RA inflow) within 8 weeks prior to the implantation
3. Suitable for TricValve® Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography
4. The subjects must have severe, tricuspid regurgitation leading to NYHA class III or IV
5. The subject has LVEF ≥ 40%
6. Distance covert in 6-minute walk test (6MWT) ≥ 60m
7. The patient shall be screened by a "Heart Team" - including an interventional cardiologist, cardiothoracic surgeon, and agreed as a candidate for TricValve® Transcatheter Bicaval Valves System implantation
8. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
9. 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 this clinical protocol
10. Optimal medical treatment of patient

Exclusion Criteria

1. Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart teams decision
2. Requirement for other elective cardiac procedures e.g. PCI (percutaneous treatment of coronary artery) or CABG (coronary artery bypass surgery) up to 90 days after the procedure or 30 days before the procedure
3. Right ventricular failure (TAPSE ≤13mmHg)
4. Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography
5. Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
6. Cerebro-vascular event within the past 3 months
7. History of mitral/tricuspid endocarditis within the last 12 months
8. Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
9. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
10. 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
11. Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately premedicated
12. Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
13. The patient has contraindication against a transesophageal echo (TEE) during the procedure
14. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
15. Liver cirrhosis Child C (see appendix)
16. Female patient of child-bearing potential
17. Psychiatric or behavioural disease including known alcohol or drug abuser that is likely to impair compliance with protocol
18. Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
19. Requirement for antibiotic treatment within the last 48 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TricValve® System Single-Arm	TricValve® System	Two self-expanding biological valves for implantation into the inferior and superior vena cava.

Primary Outcome Measures

Name	Time	Method
Kansas City Cardiomyopathy Questionnaire (KCCQ)	3 months	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.)
Percentage of participants with major adverse events	30 days	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)

Secondary Outcome Measures

Name	Time	Method
Successful implantation	Up to Discharge (≤ 10 days post index procedure)	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.
Cusp insufficiency	Up to 30 days, up to 6 months	The change of the degree of cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value
NYHA functional class	Up to 30 days	Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
Percentage of participants with major adverse events	up to 6 months	The percentage of participants with major adverse events
Device success	Up to 30 days, up to 6 months	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®.
6 Minute Walk Test	Up to 30 days, up to 6 months	Improvement in distance (m) in the 6 Minute Walk Test
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Up to 6 months	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.)
Unrestricted movement of cusps	Up to 30 days, up to 6 months	The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal)

Trial Locations

Locations (10)

Krankenhaus Nord - Klinik Floridsdorf; 🇦🇹 Vienna, Austria

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Medizinische Universität Wien; 🇦🇹 Vienna, Austria

Hospital Universitario Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Reina Sofia de Córdoba; 🇪🇸 Córdoba, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain