Clinical trial NCT06137807: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
Official title: A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Tricuspid Valve Disease
Keywords: Tricuspid Regurgitation
Heart Failure
Lead sponsor: P+F Products + Features USA Inc.
Sponsor class: INDUSTRY
Collaborators: name: P+F Products + Features GmbH
name: Meditrial USA Inc.
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter clinical trial. Subjects will be selected by their local Heart Team to be at high risk and deemed eligible by an independent eligibility committee (IEC).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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. 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.

Primary outcomes:
measure: Mortality
timeFrame: 1 Month and 12 Months
measure: Stroke
timeFrame: 1 Month
measure: Pulmonary Embolism
timeFrame: 1 Month
measure: Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
timeFrame: 1 Month
measure: Major vascular, access-related, or cardiac structural complication
timeFrame: 1 Month
measure: 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)
timeFrame: 7 Days
measure: Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
timeFrame: 1 Month
measure: Emergency surgery or intervention related to the device/procedure complications
timeFrame: 1 Month
measure: Right Ventricular Assist Device (RVAD) implantation or heart transplant
timeFrame: 12 Months
measure: Tricuspid valve surgery or percutaneous tricuspid intervention
timeFrame: 12 Months
measure: Heart Failure Events
timeFrame: 12 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
timeFrame: 12 Months
measure: New York Heart Association (NYHA class)
timeFrame: 12 Months
measure: Six Minute Walking Test (6MWT)
timeFrame: 12 Months
Secondary outcomes:
measure: Technical success of device placement (at exit from procedure room)
timeFrame: Intraprocedural
measure: Device success within 30 days after device placement
timeFrame: 1 Month
measure: Procedural success (at 30 days)
timeFrame: 1 Month
measure: Mortality
timeFrame: 12 Months
measure: RVAD implantation or heart transplant
timeFrame: 12 Months
measure: Tricuspid valve surgery or percutaneous tricuspid intervention
timeFrame: 12 Months
measure: 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
timeFrame: 12 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
timeFrame: 12 Months
measure: New York Heart Association (NYHA class)
timeFrame: 12 Months
measure: Six Minute Walking Test (6MWT)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: San Diego
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Glenview
country: United States
facility: Endeavor Health, Glenbrook Hospital
state: Illinois
city: Palos Park
country: United States
facility: Chicago Advocate Christ
state: Illinois
city: Indianapolis
country: United States
facility: Ascension Medical Group St. Vincent The Heart Center of Indiana
state: Indiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University St Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Durham
country: United States
facility: Duke Cardiology Clinic
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Services
state: Oregon
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas (Memorial Hermann)
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Institute - Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: UVA School of Medicine
state: Virginia
city: Norfolk
country: United States
facility: Sentara Healthcare
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Multiple Locations
country: United States
facility: MedStar Washington Hospital Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Products & Features GmbH
name: Katharina Kiss, MD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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 Fail. 2023 Jun;16(6):e010027. doi: 10.1161/CIRCHEARTFAILURE.122.010027. Epub 2023 Jun 6. No abstract available.