Trial Review

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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)
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
Secondary ID [1] 0 0
CTP-TRIC-005
Universal Trial Number (UTN)
Trial acronym
TRICAV
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
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
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
18 Months
Secondary outcome [5] 0 0
RVAD implantation or heart transplant
Timepoint [5] 0 0
18 Months
Secondary outcome [6] 0 0
Tricuspid valve surgery or percutaneous tricuspid intervention
Timepoint [6] 0 0
18 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
18 Months
Secondary outcome [8] 0 0
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Timepoint [8] 0 0
6 and 18 Months and annually up to 5 years
Secondary outcome [9] 0 0
New York Heart Association (NYHA class)
Timepoint [9] 0 0
6 and 18 Months and annually up to 5 years
Secondary outcome [10] 0 0
Six Minute Walking Test (6MWT)
Timepoint [10] 0 0
6 and 18 Months and annually up to 5 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
430
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [2] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Belgium
State/province [2] 0 0
Aalst
Country [3] 0 0
France
State/province [3] 0 0
Lille
Country [4] 0 0
Germany
State/province [4] 0 0
Stuttgart
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Spain
State/province [6] 0 0
Valladolid
Country [7] 0 0
Sweden
State/province [7] 0 0
Stockholm
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Newcastle Upon Tyne

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06137807
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.
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
m.tocchi@meditrial.net
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06137807