- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723239
TRICUS STUDY - Safety and Efficacy of the TricValve® Device
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania
- LSMUH Kauno Kliniko
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Female patient of child-bearing potential
- Psychiatric or behavioural disease including known alcohol or drug abuser that is likely to impair compliance with protocol
- Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
- Requirement for Antibiotic Treatment within the last 48 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TricValve® System Single-Arm
Minimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with major adverse events
Time Frame: 30 days
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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)
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30 days
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Change of New York Heart Association (NYHA) functional class
Time Frame: 6 months
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Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful implantation
Time Frame: Up to Discharge (≤ 10 days post index procedure)
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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.
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Up to Discharge (≤ 10 days post index procedure)
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Unrestricted movement of cusps
Time Frame: Up to 30 days, up to 6 months
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The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal)
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Up to 30 days, up to 6 months
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Cusp insufficiency
Time Frame: Up to 30 days, up to 6 months
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The change of the degree of cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value
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Up to 30 days, up to 6 months
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Device success
Time Frame: Up to 30 days, up to 6 months
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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®.
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Up to 30 days, up to 6 months
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NYHA functional class
Time Frame: Up to 30 days
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Number of Patients with improvement of NYHA functional class
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Up to 30 days
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6 Minute Walk Test
Time Frame: Up to 30 days, up to 6 months
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Improvement in distance (m) in the 6 Minute Walk Test
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Up to 30 days, up to 6 months
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Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Up to 30 days, up to 6 months
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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.)
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Up to 30 days, up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP-TRIC-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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