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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06137807




Registration number
NCT06137807
Ethics application status
Date submitted
31/10/2023
Date registered
18/11/2023

Titles & IDs
Public title
TRIcvalve BiCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
Scientific title
A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects with Severe Tricuspid Regurgitation - TRICAV-I Trial
Secondary ID [1] 0 0
CTP-TRIC-005
Universal Trial Number (UTN)
Trial acronym
TRICAV-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 0 0
Tricuspid Valve Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TricValve® Transcatheter Bicaval Valve System

Experimental: TricValve® Device (Device) Group - subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.


Treatment: Devices: TricValve® Transcatheter Bicaval Valve System
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
1 Month and 12 Months
Primary outcome [2] 0 0
Stroke
Timepoint [2] 0 0
1 Month
Primary outcome [3] 0 0
Pulmonary Embolism
Timepoint [3] 0 0
1 Month
Primary outcome [4] 0 0
Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
Timepoint [4] 0 0
1 Month
Primary outcome [5] 0 0
Major vascular, access-related, or cardiac structural complication
Timepoint [5] 0 0
1 Month
Primary outcome [6] 0 0
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)
Timepoint [6] 0 0
7 Days
Primary outcome [7] 0 0
Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
Timepoint [7] 0 0
1 Month
Primary outcome [8] 0 0
Emergency surgery or intervention related to the device/procedure complications
Timepoint [8] 0 0
1 Month
Primary outcome [9] 0 0
Right Ventricular Assist Device (RVAD) implantation or heart transplant
Timepoint [9] 0 0
12 Months
Primary outcome [10] 0 0
Tricuspid valve surgery or percutaneous tricuspid intervention
Timepoint [10] 0 0
12 Months
Primary outcome [11] 0 0
Heart Failure Events
Timepoint [11] 0 0
12 Months
Primary outcome [12] 0 0
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Timepoint [12] 0 0
12 Months
Primary outcome [13] 0 0
New York Heart Association (NYHA class)
Timepoint [13] 0 0
12 Months
Primary outcome [14] 0 0
Six Minute Walking Test (6MWT)
Timepoint [14] 0 0
12 Months
Secondary outcome [1] 0 0
Technical success of device placement (at exit from procedure room)
Timepoint [1] 0 0
Intraprocedural
Secondary outcome [2] 0 0
Device success within 30 days after device placement
Timepoint [2] 0 0
1 Month
Secondary outcome [3] 0 0
Procedural success (at 30 days)
Timepoint [3] 0 0
1 Month
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
RVAD implantation or heart transplant
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Tricuspid valve surgery or percutaneous tricuspid intervention
Timepoint [6] 0 0
12 Months
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Timepoint [8] 0 0
12 Months
Secondary outcome [9] 0 0
New York Heart Association (NYHA class)
Timepoint [9] 0 0
12 Months
Secondary outcome [10] 0 0
Six Minute Walking Test (6MWT)
Timepoint [10] 0 0
12 Months

Eligibility
Key inclusion criteria
1. Subject must be 18 years or older, at the time of signing the informed consent.
2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
4. Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.
5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
6. For females of childbearing potential, negative pregnancy test.
7. Capable of giving signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).
3. LVEF = 30% on echocardiography.
4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 [at least 0.75 if BMI >30 kg/m2], DVI <2.2, mean gradient <5mm Hg); reduction of total tricuspid regurgitation to optimal (= mild [1+]) or acceptable (= moderate [2+]).
6. Severe right ventricular dysfunction.
7. Cardiac amyloidosis
8. Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
10. Hemodynamically significant pericardial effusion.
11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
13. Unable to tolerate anticoagulation/antiplatelet therapy
14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
15. Any known life-threatening condition with an estimated life span of at least 12 months.
16. Platelet count < 75,000/mm3
17. Child-Pugh Severity Class C (10-15 points).
18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) = 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
19. Endocarditis or active/ongoing infection requiring antibiotics.
20. Unable to walk at least 60 meters in a 6minute walk test.
21. Known bleeding or clotting disorders or patient refuses blood transfusion.
22. Active gastrointestinal (GI) bleeding within 3 months of randomization.
23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2029
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
P+F Products + Features USA Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
P+F Products + Features GmbH
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Meditrial USA Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katharina Kiss, MD
Address 0 0
Products & Features GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Monica Tocchi, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
9176841700
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06137807