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

• ClinicalTrials.gov Identifier: NCT04141137
• Recruitment Status: Completed
• First Posted: October 28, 2019
• Last Update Posted: April 20, 2022
• Sponsor: P+F Products + Features GmbH
• Information provided by (Responsible Party): P+F Products + Features GmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Severe Tricuspid Regurgitation	Device: TricValve® System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 9, 2019
• Actual Primary Completion Date: May 5, 2021
• Actual Study Completion Date: December 2, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: TricValve® System Single-Arm; Two self-expanding biological valves for implantation into the inferior and superior vena cava.	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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants with major adverse events [ Time Frame: 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)
2. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 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.)

Secondary Outcome Measures :

1. Percentage of participants with major adverse events [ Time Frame: up to 6 months ]
   The percentage of participants with major adverse events
2. Successful implantation [ Time Frame: 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.
3. Unrestricted movement of cusps [ Time Frame: 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)
4. Cusp insufficiency [ Time Frame: 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
5. Device success [ Time Frame: 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. NYHA functional class [ Time Frame: Up to 30 days ]
   Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
7. 6 Minute Walk Test [ Time Frame: Up to 30 days, up to 6 months ]
   Improvement in distance (m) in the 6 Minute Walk Test
8. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 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.)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Medizinische Universität Wien

Vienna, Austria, 1090

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

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, Spain

Sponsors and Collaborators

P+F Products + Features GmbH

Investigators

• Principal Investigator: Alexander Lauten, Prof.Dr.med.; Charite University, Berlin, Germany
• Principal Investigator: Iniguez Romo Andrés, Dr.; Hospital Universitario Alvaro Cunqueiro- Vigo
• Principal Investigator: Christian Hengstenberg, UnivProf.Dr.; Medical University of Vienna

More Information

• Responsible Party: P+F Products + Features GmbH
• ClinicalTrials.gov Identifier: NCT04141137
• Other Study ID Numbers: CTP-TRIC-002
• First Posted: October 28, 2019
• Last Update Posted: April 20, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by P+F Products + Features GmbH:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases