TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV)

Tricuspid Regurgitation Clinical Trial

— TRICAV  

Official title:

A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06137807
• Other study ID #: CTP-TRIC-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: November 2029

Study information

• Verified date: May 2024
• Source: P+F Products + Features USA Inc.
• Contact: Monica Tocchi, MD, PhD
• Phone: 9176841700
• Email: m.tocchi[@]meditrial.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 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.

Description:

This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery. Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 2029
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Northshore Evanston Hospital	Evanston	Illinois
United States	UPMC Pinnacle	Harrisburg	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Houston Methodist	Houston	Texas
United States	University of Texas (Memorial Hermann)	Houston	Texas
United States	Ascension Medical Group St. Vincent The Heart Center of Indiana	Indianapolis	Indiana
United States	Columbia University Medical Center/ NewYork Presbyterian Hospital	Irving	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	MedStar Washington Hospital Center	Multiple Locations	Washington
United States	Intermountain Heart Institute - Intermountain Medical Center	Murray	Utah
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Scripps Memorial Hospital La Jolla	San Diego	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
P+F Products + Features USA Inc.	Meditrial USA Inc., P+F Products + Features GmbH

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Chandran K, Long A, Bishop J, Berman P, Matar F, Oliveira GH, Bezerra HG. First In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation. Circ Heart Fa — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of days until death	1 Month and 12 Months
Primary	Stroke	Number of days until death	1 Month
Primary	Pulmonary Embolism	Number of days until death	1 Month
Primary	Valve Academic Research Consortium (VARC) type 2-4 bleeding complication	Number of days until death	1 Month
Primary	Major vascular, access-related, or cardiac structural complication	Number of days until death	1 Month
Primary	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)	Number of days from baseline until increase	7 Days
Primary	Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy	Number of days until new renal replacement therapy	1 Month
Primary	Emergency surgery or intervention related to the device/procedure complications	Number of days until emergency surgery or intervention	1 Month
Primary	Right Ventricular Assist Device (RVAD) implantation or heart transplant	Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant	12 Months
Primary	Tricuspid valve surgery or percutaneous tricuspid intervention	Number of days until tricuspid valve surgery or percutaneous tricuspid intervention	12 Months
Primary	Heart Failure Events	Number of heart failure episodes including hospitalization, or worsening heart failure	12 Months
Primary	Kansas City Cardiomyopathy Questionnaire (KCCQ) Score	Change in KCC score (score ranges between 0 and 100)	12 Months
Primary	New York Heart Association (NYHA class)	Change in NYHA class (range from I to IV)	12 Months
Primary	Six Minute Walking Test (6MWT)	Change in walking distance	12 Months
Secondary	Technical success of device placement (at exit from procedure room)	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	Intraprocedural
Secondary	Device success within 30 days after device placement	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	1 Month
Secondary	Procedural success (at 30 days)	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	1 Month
Secondary	Mortality	Number of days until death	12 Months
Secondary	RVAD implantation or heart transplant	Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant	12 Months
Secondary	Tricuspid valve surgery or percutaneous tricuspid intervention	Number of days until tricuspid valve surgery or percutaneous tricuspid intervention	12 Months
Secondary	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	Number of days until Heart Failure hospitalization or worsening Heart Failure	12 Months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) Score	Change in KCCQ score (score ranges between 0 and 100)	12 Months
Secondary	New York Heart Association (NYHA class)	Change in NYHA class (range from I to IV)	12 Months
Secondary	Six Minute Walking Test (6MWT)	Change in walking distance	12 Months

External Links

•   Description: Products & Features, manufacturer of TricValve® Transcatheter Bicaval Valve System
•   Meditrial Clinical Research Organization