RECRUITING

TRIcvalve BiCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

Conditions

Tricuspid Regurgitation Tricuspid Valve Disease Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-23

Study Completion:2029-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06137807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Monica Tocchi, MD, PhD

CONTACT

9176841700

m.tocchi@meditrial.net

Principal Investigator

Katharina Kiss, MD

STUDY_CHAIR

Products & Features GmbH

Study Locations (Sites)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

United States

Scripps Memorial Hospital La Jolla

San Diego, California, 92037

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Northshore Evanston Hospital

Evanston, Illinois, 60201

United States

Ascension Medical Group St. Vincent The Heart Center of Indiana

Indianapolis, Indiana, 46260

United States

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

Columbia University Medical Center/ NewYork Presbyterian Hospital

Irving, New York, 10032

United States

Cleveland Clinic

Cleveland, Ohio, 44106

United States

UPMC Pinnacle

Harrisburg, Pennsylvania, 17107

United States

Houston Methodist

Houston, Texas, 77030

United States

University of Texas (Memorial Hermann)

Houston, Texas, 77030

United States

Intermountain Heart Institute - Intermountain Medical Center

Murray, Utah, 84107

United States

MedStar Washington Hospital Center

Multiple Locations, Washington, 20010

United States

Collaborators and Investigators

Sponsor: P+F Products + Features USA Inc.

Katharina Kiss, MD, STUDY_CHAIR, Products & Features GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-23

Study Completion Date2029-09

Study Record Updates

Study Start Date2024-07-23

Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

Tricuspid Regurgitation
Heart Failure

Additional Relevant MeSH Terms

Tricuspid Regurgitation
Tricuspid Valve Disease