TRICUS STUDY - Safety and Efficacy of the TricValve® Device

NCT03723239 | Completed

• 1 other identifier: CTP-TRIC-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

• Change of New York Heart Association (NYHA) functional class

  Change of New York Heart Association (NYHA) functional class from III or IV to a lower one

  6 months

Secondary Outcomes (7)

• 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

• NYHA functional class

  Up to 30 days

Study Arms (1)

TricValve® System Single-Arm

EXPERIMENTAL

Minimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement

Device: TricValve® System

Interventions

TricValve® System DEVICE

The TricValve® Delivery System 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 unsheathed 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 right atrium (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 New York Heart Association (NYHA) class III or IV
• The subject has left ventricular ejection fraction (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 the 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 the clinical protocol

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. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) 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 (noncardiac 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 (1)

LSMUH Kauno Kliniko

Kaunas, Lithuania

Location

Related Publications (1)

• Blasco-Turrion S, Briedis K, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016/j.jcin.2023.10.043. Epub 2023 Dec 6.

  PMID: 38069986 DERIVED

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

• Rimantas Benetis, Prof.

  Hospital of Lithuanian University of Health Sciences Kauno Klinikos

  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 25, 2018
• First Posted: October 29, 2018
• Study Start: September 12, 2018
• Primary Completion: September 4, 2020
• Study Completion: November 15, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)