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

NCT ID: NCT04141137

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2021-12-02

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.

Conditions

Severe Tricuspid Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TricValve® System Single-Arm

Two self-expanding biological valves for implantation into the inferior and superior vena cava.

Group Type: EXPERIMENTAL

TricValve® System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

P+F Products + Features GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Lauten, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Iniguez Romo Andrés, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Alvaro Cunqueiro- Vigo

Christian Hengstenberg, UnivProf.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medizinische Universität Wien

Vienna, , Austria

Krankenhaus Nord - Klinik Floridsdorf

Vienna, , Austria

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, , Spain

Countries

Austria; Spain

Other Identifiers

CTP-TRIC-002

Identifier Type: -

Identifier Source: org_study_id