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

Severe Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141137
• Other study ID #: CTP-TRIC-002
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: December 2, 2021

Study information

• Verified date: April 2022
• Source: P+F Products + Features GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Severe Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• TricValve® System
The TricValve® Delivery System (catheter) with already pre-mounted biological heart valve 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 released at the implantation site and positions itself as per the anatomy - self expanding frame.

Locations

Country	Name	City	State
Austria	Krankenhaus Nord - Klinik Floridsdorf	Vienna
Austria	Medizinische Universität Wien	Vienna
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario Reina Sofia de Córdoba	Córdoba
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Alvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
P+F Products + Features GmbH

Countries where clinical trial is conducted

Austria,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.)	3 months
Secondary	Percentage of participants with major adverse events	The percentage of participants with major adverse events	up to 6 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	NYHA functional class	Change of New York Heart Association (NYHA) functional class from III or IV to a lower one	Up to 30 days
Secondary	6 Minute Walk Test	Improvement in distance (m) in the 6 Minute Walk Test	Up to 30 days, up to 6 months
Secondary	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 6 months