TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.

Tricuspid Regurgitation Clinical Trial

— TRICAV-II  

Official title:

A Prospective, Multicenter, Randomized, Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation (TR).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458907
• Other study ID #: CTP-TRIC-005-II
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: January 2030

Study information

• Verified date: June 2024
• Source: P+F Products + Features USA Inc.
• Contact: Monica Tocchi, MD, PhD
• Phone: +1 646-933-1025
• Email: m.tocchi[@]meditrial.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System).

The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior and inferior vena cava.

The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.

Description:

This is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with OMT compared to OMT alone in the treatment of patients with severe TR and caval reflux.

The TricValve System received Breakthrough Device Designation from the US FDA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject must be 18 years or older.

2. Severe tricuspid regurgitation (TR), as determined by Echo Core Lab.

3. NYHA Class III-IVa or heart failure (HF) admission in the past 6 months.

4. Subject is treated with stable OMT for at least 30 days.

5. The local Heart Team and IEC determine that the patient is eligible

6. For females of childbearing potential, negative pregnancy test.

7. Capable and willing to provide signed informed consent.

Exclusion Criteria:

1. Recent MI, stroke or CVA; major cardiovascular surgery within 90 days.

2. Subject requires another planned major cardiac procedure.

3. LVEF = 30% on echocardiography.

4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.

5. Tricuspid stenosis.

6. Severe right ventricular dysfunction.

7. Cardiac amyloidosis.

8. Pulmonary artery systolic pressure (PASP) >65 mmHg.

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

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. Life expectancy lower than 12 months.

16. Platelet count < 75,000/mm3.

17. Child-Pugh Severity Class C (10-15 points).

18. Severe renal insufficiency with eGFR) = 25 mL/min/1.73 m2 or dialysis.

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 TricValve procedure.

23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.

24. Participation in other investigational devices or drug 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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Device:
• TricValve® Transcatheter Bicaval Valve System
TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.

Drug:
• Optimal medical therapy
Optimal medical therapy

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 (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Blasco-Turrion S, Briedis K, 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, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of Cardiovascular Deaths at 30 Days.	1 Month, 12 Months
Primary	Q-wave myocardial infarctions	Number of myocardial infarctions at 30 Days.	1 Month
Primary	Disabling stroke	Number of days until death.	1 Month
Primary	Life threatening bleeding	Number of days until death.	1 Month
Primary	Pulmonary embolism	Number of days until death.	1 Month
Primary	Renal failure requiring dialysis	Number of days until new renal replacement therapy.	1 Month
Primary	Major access-site, vascular, or cardiac structural complications	Number of days until death.	1 Month
Primary	Emergency surgery or intervention related to the device/procedure complications	Number of days until emergency surgery or intervention.	1 Month
Primary	Reduction in caval reflux	Reduction in CA, measured by echocardiography	6 Months
Primary	Kansas City Cardiomyopathy Questionnaire (KCCQ Score)	Change in KCCQ score (score ranges between 0 and 100)	6 Months, 12 Months
Primary	New York Heart Association (NYHA Class)	Change in NYHA class (range from I to IV)	6 Months, 12 Months
Primary	Six Minute Walking Test (6MWT)	Change in walking distance	6 Months, 12 Months
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
Secondary	Secondary Safety Endpoint (measured at 1 year)	The percentage of subjects with Device- and/or Procedure-related MAEs through 1 year.	12 Months
Secondary	All-Cause mortality	Number of days until death.	3 Months, 6 Months, and 12 Months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ Score)	Change in KCCQ score (score ranges between 0 and 100)	3 Months, 6 Months, and 12 Months
Secondary	Right Ventricular Assist Device (RVAD) implantation or heart transplant	Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant.	3 Months, 6 Months, and 12 Months
Secondary	Six Minute Walking Test (6MWT)	Change in walking distance	3 Months, 6 Months, and 12 Months
Secondary	Atrial Fibrillation	Days to new onset of atrial fibrillation.	3 Months, 6 Months, and 12 Months

External Links

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