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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06137807
Registration number
NCT06137807
Ethics application status
Date submitted
31/10/2023
Date registered
18/11/2023
Date last updated
18/11/2023
Titles & IDs
Public title
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation Regurgitation (TRICAV)
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Scientific title
Prospective, Multicenter, Randomized, Controlled Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Symptomatic Tricuspid Regurgitation (TR) - TRICAV Trial
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Secondary ID [1]
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CTP-TRIC-005
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Universal Trial Number (UTN)
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Trial acronym
TRICAV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation
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Tricuspid Valve Disease
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - TricValve® Transcatheter Bicaval Valve System
Treatment: Surgery - Medical Therapy Arm
Experimental: TricValve® Device (Device) Group - subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.
Placebo Comparator: Control Arm Treatment Group - subjects will continue to be managed on local standard of care (SOC) therapy for severe TR per physician discretion.
Treatment: Devices: TricValve® Transcatheter Bicaval Valve System
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve implantation system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.
Treatment: Surgery: Medical Therapy Arm
Subjects will be randomized and managed on standard of care therapy, per physician discretion.
*Ability to cross-over after 18-Month Follow-Up completed
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
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Number of days until death
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Timepoint [1]
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1 Month and 12 Months
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Primary outcome [2]
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Stroke
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Assessment method [2]
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Number of days until death
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Timepoint [2]
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1 Month
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Primary outcome [3]
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Pulmonary Embolism
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Assessment method [3]
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Number of days until death
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Timepoint [3]
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1 Month
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Primary outcome [4]
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Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
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Assessment method [4]
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Number of days until death
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Timepoint [4]
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1 Month
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Primary outcome [5]
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Major vascular, access-related, or cardiac structural complication
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Assessment method [5]
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Number of days until death
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Timepoint [5]
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1 Month
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Primary outcome [6]
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Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine =4.0mg/dL (=354 µmol/L) with an acute increase of = 0.5 mg/dL (=44 µmol/L)
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Assessment method [6]
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Number of days from baseline until increase
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Timepoint [6]
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7 Days
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Primary outcome [7]
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Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
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Assessment method [7]
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Number of days until new renal replacement therapy
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Timepoint [7]
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1 Month
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Primary outcome [8]
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Emergency surgery or intervention related to the device/procedure complications
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Assessment method [8]
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Number of days until emergency surgery or intervention
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Timepoint [8]
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1 Month
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Primary outcome [9]
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Right Ventricular Assist Device (RVAD) implantation or heart transplant
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Assessment method [9]
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Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
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Timepoint [9]
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12 Months
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Primary outcome [10]
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Tricuspid valve surgery or percutaneous tricuspid intervention
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Assessment method [10]
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Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
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Timepoint [10]
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12 Months
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Primary outcome [11]
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Heart Failure Events
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Assessment method [11]
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Number of heart failure episodes including hospitalization, or worsening heart failure
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Timepoint [11]
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12 Months
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Primary outcome [12]
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
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Assessment method [12]
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Change in KCC score (score ranges between 0 and 100)
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Timepoint [12]
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12 Months
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Primary outcome [13]
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New York Heart Association (NYHA class)
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Assessment method [13]
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Change in NYHA class (range from I to IV)
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Timepoint [13]
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12 Months
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Primary outcome [14]
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Six Minute Walking Test (6MWT)
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Assessment method [14]
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Change in walking distance
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Timepoint [14]
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12 Months
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Secondary outcome [1]
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Technical success of device placement (at exit from procedure room)
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Assessment method [1]
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Freedom from mortality
Successful access, delivery of the device, and retrieval of the delivery system
Correct positioning of the device into the proper anatomical location
Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
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Timepoint [1]
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Intraprocedural
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Secondary outcome [2]
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Device success within 30 days after device placement
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Assessment method [2]
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Technical success
Freedom from mortality
Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
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Timepoint [2]
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1 Month
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Secondary outcome [3]
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Procedural success (at 30 days)
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Assessment method [3]
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All of the following criteria must be met to be considered a procedural success:
Device success (defined above), and
Absence of major device or procedure related serious adverse events
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Timepoint [3]
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1 Month
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Secondary outcome [4]
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Mortality
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Assessment method [4]
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Number of days until death
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Timepoint [4]
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18 Months
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Secondary outcome [5]
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RVAD implantation or heart transplant
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Assessment method [5]
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Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
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Timepoint [5]
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18 Months
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Secondary outcome [6]
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Tricuspid valve surgery or percutaneous tricuspid intervention
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Assessment method [6]
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Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
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Timepoint [6]
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18 Months
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Secondary outcome [7]
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Heart Failure hospitalization or worsening Heart Failure (HF) which encompasses treatment with IV diuretics in the office or Emergency Department treatment during a <24-hour time period
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Assessment method [7]
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Number of days until Heart Failure hospitalization or worsening Heart Failure
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Timepoint [7]
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18 Months
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Secondary outcome [8]
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
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Assessment method [8]
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Change in KCCQ score (score ranges between 0 and 100)
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Timepoint [8]
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6 and 18 Months and annually up to 5 years
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Secondary outcome [9]
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New York Heart Association (NYHA class)
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Assessment method [9]
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Change in NYHA class (range from I to IV)
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Timepoint [9]
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6 and 18 Months and annually up to 5 years
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Secondary outcome [10]
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Six Minute Walking Test (6MWT)
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Assessment method [10]
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Change in walking distance
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Timepoint [10]
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6 and 18 Months and annually up to 5 years
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Eligibility
Key inclusion criteria
- Subject must be 18 years or older, at the time of signing the informed consent.
- Subjects must have severe TR. TR severity is determined by the assessment of a
qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core
Lab. The Core Lab may request a trans-esophageal echocardiogram (TEE) or cardiac
magnetic resonance imaging (CMR).
- Subject has been optimally medically managed for heart failure per applicable
standards and stable for at least 30 days.
- The site Heart Team (consisting of 1 Interventional Cardiologist, 1 Cardiac Surgeon, 1
Imaging Cardiologist, 1 Heart Failure Specialist) and the Independent Eligibility
Committee (IEC) judges the subject to be high risk for tricuspid valve surgery.
Inclusion is limited to subjects with severe symptomatic TR who are not candidates for
approved transcatheter tricuspid valve device.
- NYHA Class 3-4 (not on inotropes) OR HF admission in the past 6 months.
- Significant IVC and/or SVC backflow on echocardiography, and vwave =20mmHg on right
heart catheterization (measured in IVC and or SVC 2-4cm above/below the RA inflow).
- Anatomically suitable for the TricValve Device per CT and right heart catheterization.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Requirement of another planned cardiac procedure (i.e., PCI) up to 30 days pre- or
post- procedure
- Left Ventricular Ejection Fraction (LVEF) =30% on echocardiography
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus
or vegetation
- Invasive pulmonary artery systolic pressure >65 mmHg
- Recent Cerebrovascular Accident (CVA) (within 3 months)
- Need for left-sided or pulmonary valve treatment within 60 days of screening
- Tricuspid stenosis
- Thrombosis of lower extremity veins or presence of an IVC filter
- Unable to take Coumadin or Direct Oral Anticoagulants (DOAC)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/01/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2029
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Actual
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Sample size
Target
430
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Jessie McPherson Private Hospital - Clayton
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Recruitment hospital [2]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Ohio
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Country [2]
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Belgium
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State/province [2]
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Aalst
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Country [3]
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France
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State/province [3]
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Lille
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Country [4]
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Germany
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State/province [4]
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Stuttgart
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Country [5]
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Spain
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State/province [5]
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Barcelona
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Country [6]
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Spain
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State/province [6]
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Valladolid
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Country [7]
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Sweden
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State/province [7]
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Stockholm
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Country [8]
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United Kingdom
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State/province [8]
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London
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Country [9]
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United Kingdom
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State/province [9]
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
P+F Products + Features GmbH
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Meditrial USA Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve
implantation system, which includes the TricValve® Transcatheter Bicaval Valve for superior
vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC).
The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery
System which is used for percutaneous access and delivery of the TricValve® Transcatheter
Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with
all the valve sizes. The prostheses are implanted percutaneously into the inferior and
superior vena cava without disturbing the native tricuspid valve. The device is made of
bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06137807
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Trial related presentations / publications
Estevez-Loureiro R, Sanchez-Recalde A, Amat-Santos IJ, Cruz-Gonzalez I, Baz JA, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Salido-Tahoces L, Santos-Martinez S, Nunez JC, Moris C, Goliasch G, Jimenez-Quevedo P, Ojeda S, Cid-Alvarez B, Santiago-Vacas E, Jimenez-Valero S, Serrador A, Martin-Moreiras J, Strouhal A, Hengstenberg C, Zamorano JL, Puri R, Iniguez-Romo A. 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1366-1377. doi: 10.1016/j.jcin.2022.05.022. Epub 2022 May 17.
Amat-Santos IJ, 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, Blasco-Turrion S, Sanchez-Luna JP, Revilla-Orodoea A, Redondo A, Zamorano JL, Puri R, Iniguez-Romo A, San Roman A. Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. EuroIntervention. 2023 Aug 7;19(5):e450-e452. doi: 10.4244/EIJ-D-23-00077. No abstract available.
Abdul-Jawad Altisent O, Codina P, Puri R, Bayes-Genis A. Transcatheter bi-caval valve implantation (CAVI) significantly improves cardiac output: mechanistic insights following CardioMEMS(R) and TricValve(R) implantation. Clin Res Cardiol. 2022 Aug;111(8):966-968. doi: 10.1007/s00392-022-02029-8. Epub 2022 May 2. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Katharina Kiss, MD
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Address
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Products & Features GmbH
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Monica Tocchi, MD, PhD
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Address
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Phone
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9176841700
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06137807
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