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

NCT06458907 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CTP-TRIC-005-II
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 15

Brief 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 vena cava (SVC) and inferior vena cava (IVC). 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.

Conditions

Tricuspid Regurgitation; Tricuspid Valve Disease

Keywords

Tricuspid Regurgitation; Heart Failure

Outcome Measures

Primary Outcomes (15)

• Mortality

  Number of Cardiovascular Deaths at 30 Days.

  1 Month, 12 Months

• Q-wave myocardial infarctions

  Number of myocardial infarctions at 30 Days.

  1 Month

• Disabling stroke

  Number of days until death.

  1 Month

• Life threatening bleeding

  Number of days until death.

  1 Month

• Pulmonary embolism

  Number of days until death.

  1 Month

• Renal failure requiring dialysis

  Number of days until new renal replacement therapy.

  1 Month

• Major access-site, vascular, or cardiac structural complications

  Number of days until death.

  1 Month

• Emergency surgery or intervention related to the device/procedure complications

  Number of days until emergency surgery or intervention.

  1 Month

• Reduction in Caval Reflux (CR)

  Reduction in CR, measured by echocardiography

  6 Months

• Kansas City Cardiomyopathy Questionnaire (KCCQ Score)

  Change in KCCQ score (score ranges between 0 and 100)

  6 Months, 12 Months

• New York Heart Association (NYHA Class)

  Change in NYHA class (range from I to IV)

  6 Months, 12 Months

• Six Minute Walking Test (6MWT)

  Change in walking distance

  6 Months, 12 Months

• Right Ventricular Assist Device (RVAD) implantation or heart transplant

  Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant

  12 Months

• Tricuspid valve surgery or percutaneous tricuspid intervention

  Number of days until tricuspid valve surgery or percutaneous tricuspid intervention

  12 Months

• Heart Failure Events

  Number of heart failure episodes including hospitalization, or worsening heart failure

  12 Months

Secondary Outcomes (6)

• Secondary Safety Endpoint (measured at 1 year)

  12 Months

• All-Cause mortality

  3 Months, 6 Months, and 12 Months

• Kansas City Cardiomyopathy Questionnaire (KCCQ Score)

  3 Months, 6 Months, and 12 Months

• Right Ventricular Assist Device (RVAD) implantation or heart transplant

  3 Months, 6 Months, and 12 Months

• Six Minute Walking Test (6MWT)

  3 Months, 6 Months, and 12 Months

Study Arms (3)

TricValve® Device (Device) + Optimal medical therapy (OMT)

EXPERIMENTAL

TricValve® Device (Device) + OMT

Device: TricValve® Transcatheter Bicaval Valve System; Drug: Optimal medical therapy

Optimal medical therapy (OMT) Alone

ACTIVE COMPARATOR

OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.

Drug: Optimal medical therapy

TricValve Single Arm Registry

EXPERIMENTAL

Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.

Device: TricValve® Transcatheter Bicaval Valve System; Drug: Optimal medical therapy

Interventions

TricValve® Transcatheter Bicaval Valve System DEVICE

TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.

Also known as: TricValve System

TricValve Single Arm Registry; TricValve® Device (Device) + Optimal medical therapy (OMT)

Optimal medical therapy DRUG

Optimal medical therapy

Also known as: OMT

Optimal medical therapy (OMT) Alone; TricValve Single Arm Registry; TricValve® Device (Device) + Optimal medical therapy (OMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be 18 years or older.
• Severe tricuspid regurgitation (TR), as determined by Echo Core Lab.
• NYHA Class III-IVa or heart failure (HF) admission in the past 6 months.
• Subject is treated with stable OMT for at least 30 days.
• The local Heart Team and Independent Eligibility Committee (IEC) determine that the patient is eligible
• For females of childbearing potential, negative pregnancy test.
• Capable and willing to provide signed informed consent.

You may not qualify if:

• Recent Myocardial Infarction (MI), stroke or Cerebrovascular Accident (CVA); major cardiovascular surgery within 90 days.
• Subject requires another planned major cardiac procedure.
• Left Ventricular Ejection Fraction (LVEF) ≤ 30% on echocardiography.
• Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
• Tricuspid stenosis.
• Severe right ventricular dysfunction.
• Cardiac amyloidosis.
• Pulmonary artery systolic pressure (PASP) \>65 mmHg.
• Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
• Hemodynamically significant pericardial effusion.
• Patient with refractory heart failure requiring advanced intervention
• Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
• Unable to tolerate anticoagulation/antiplatelet therapy.
• Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
• Life expectancy lower than 12 months.

Sponsors & Collaborators

• P+F Products + Features USA Inc.: lead
• Meditrial USA Inc.: collaborator

Study Sites (15)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Scripps Memorial Hospital La Jolla

San Diego, California, 92037, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Northshore Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Ascension Medical Group St. Vincent The Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Columbia University Medical Center/ NewYork Presbyterian Hospital

Irving, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17107, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Texas (Memorial Hermann)

Houston, Texas, 77030, United States

Location

Intermountain Heart Institute - Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MedStar Washington Hospital Center

Multiple Locations, Washington, 20010, United States

Location

Related 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.

  PMID: 37083622 BACKGROUND

• 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, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016/j.jcin.2023.10.043. Epub 2023 Dec 6.

  PMID: 38069986 RESULT

Related Links

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

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Monica Tocchi, MD, PhD

CONTACT

+1 646-933-1025; m.tocchi@meditrial.net

Paul Shelton

CONTACT

1-832-622-0209; pshelton@productsandfeatures.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 14, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)