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Trial record 2 of 3 for:    Tricvalve | Tricuspid Regurgitation

TRICUS STUDY - Safety and Efficacy of the TricValve® Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723239
Recruitment Status : Completed
First Posted : October 29, 2018
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
P+F Products + Features GmbH

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date April 20, 2022
Actual Study Start Date  ICMJE September 12, 2018
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • 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)
  • Change of New York Heart Association (NYHA) functional class [ Time Frame: 6 months ]
    Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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)
  • Improvement of New York Heart Association (NYHA) functional class [ Time Frame: 6 months ]
    Improvement of New York Heart Association (NYHA) functional class
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2021)
  • 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.
  • 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)
  • 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
  • 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®.
  • NYHA functional class [ Time Frame: Up to 30 days ]
    Number of Patients with improvement of NYHA functional class
  • 6 Minute Walk Test [ Time Frame: Up to 30 days, up to 6 months ]
    Improvement in distance (m) in the 6 Minute Walk Test
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Up to 30 days, 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.)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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.
  • Unrestricted movement of cusps [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]
    The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal)
  • Cusp insufficiency [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]
    The reduction of the degree of cusp insufficiency as assessed with echocardiography (ordinal)
  • Device success [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]
    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®.
  • NYHA functional class [ Time Frame: Up to 30 days, up to 5 years ]
    Number of Patients with improvement of NYHA functional class
  • 6 Minute Walk Test [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]
    Improvement in distance (m) in the 6 Minute Walk Test
  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]
    Number of Patients with improvement in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRICUS STUDY - Safety and Efficacy of the TricValve® Device
Official Title  ICMJE TRICUS STUDY - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation.
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 is designed to investigate the safety and performance for at least 30 days and up to 6 months.

The study has been approved by the Kaunas Regional Biomedical Research Ethics Committee.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Tricuspid Regurgitation
Intervention  ICMJE Device: TricValve® System
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.
Study Arms  ICMJE Experimental: TricValve® System Single-Arm
Minimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement
Intervention: Device: TricValve® System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2022)
9
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2018)
10
Actual Study Completion Date  ICMJE November 15, 2021
Actual Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 right atrium (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 New York Heart Association (NYHA) class III or IV
  5. The subject has left ventricular ejection fraction (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 the 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 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

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. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) 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 (noncardiac 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723239
Other Study ID Numbers  ICMJE CTP-TRIC-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party P+F Products + Features GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE P+F Products + Features GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Lauten, Prof.Dr.med. Charite University, Berlin, Germany
Principal Investigator: Rimantas Benetis, Prof. Hospital of Lithuanian University of Health Sciences Kauno Klinikos
PRS Account P+F Products + Features GmbH
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP