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

NCT04141137 | Completed DMC

• 1 other identifier: CTP-TRIC-002
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 10

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.

Conditions

Severe Tricuspid Regurgitation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Percentage of participants with major adverse events

  up to 6 months

• Successful implantation

  Up to Discharge (≤ 10 days post index procedure)

• Unrestricted movement of cusps

  Up to 30 days, up to 6 months

• Cusp insufficiency

  Up to 30 days, up to 6 months

• Device success

  Up to 30 days, up to 6 months

Study Arms (1)

TricValve® System Single-Arm

EXPERIMENTAL

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

Device: TricValve® System

Interventions

TricValve® System 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.

TricValve® System Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 NYHA class III or IV
• The subject has 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 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 this clinical protocol
• Optimal medical treatment of patient

You may not qualify if:

• 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. 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
• Right ventricular failure (TAPSE ≤13mmHg)
• Systolic pulmonary arterial pressure \> 65 mmHg as assessed by Doppler echocardiography
• 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
• 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)

Sponsors & Collaborators

• P+F Products + Features GmbH: lead

Study Sites (10)

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Universitario Reina Sofia de Córdoba

Córdoba, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Hospital Universitario Alvaro Cunqueiro

Vigo, Spain

Location

MeSH Terms

Conditions

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: December 9, 2019
• Primary Completion: May 5, 2021
• Study Completion: December 2, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); ES (8)