Actively Recruiting
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
Led by P+F Products + Features USA Inc. · Updated on 2025-06-08
50
Participants Needed
36
Research Sites
266 weeks
Total Duration
On this page
Sponsors
P
P+F Products + Features USA Inc.
Lead Sponsor
P
P+F Products + Features GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Severe tricuspid regurgitation confirmed by transthoracic echocardiogram and Core Lab
- NYHA Class III-IVa or heart failure admission within past 6 months
- Receiving optimal medical therapy for heart failure including a diuretic for at least 30 days prior to procedure
- Eligible for TricValve procedure as determined by local Heart Team and IEC
- Negative pregnancy test for females of childbearing potential
- Capable of giving signed informed consent
You will not qualify if you...
- Recent myocardial infarction, stroke, coronary artery bypass graft, percutaneous coronary intervention, or major cardiac surgery within 90 days prior to TricValve implantation
- Planned major cardiac procedures such as left-sided transcatheter intervention or surgery, coronary artery bypass, PCI, or pulmonary valve correction (except ASD/PFO closure or electrophysiology procedures with 30-day delay)
- Left ventricular ejection fraction 30% or less
- Intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
- Tricuspid stenosis per echocardiographic criteria
- Severe right ventricular dysfunction
- Cardiac amyloidosis
- Pulmonary artery systolic pressure over 65 mmHg
- Lower extremity venous thrombosis or presence of inferior vena cava filter within 6 months
- Significant pericardial effusion
- Refractory heart failure requiring advanced interventions
- Allergies to nitinol, bovine tissue, or contrast media not manageable with pre-medication
- Inability to tolerate anticoagulation or antiplatelet therapy
- Hemodynamic instability, cardiogenic shock, or acute heart failure within 30 days prior to procedure
- Life-threatening condition with estimated survival less than 12 months
- Platelet count below 75,000/mm3
- Child-Pugh Class C liver disease
- Severe renal insufficiency (eGFR 25 mL/min/1.73 m2 or less) or chronic renal replacement therapy
- Active infection requiring antibiotics or endocarditis
- Unable to walk at least 60 meters in six-minute walk test
- Known bleeding or clotting disorders or refusal of blood transfusion
- Active gastrointestinal bleeding within 3 months
- Significant congenital heart disease
- Participation in other investigational cardiovascular studies without reaching primary endpoint
- Any condition precluding study requirements per investigator
- Psychiatric, behavioral, medical, or social conditions preventing valid consent or follow-up
- Pregnant or breastfeeding or planning pregnancy during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Tucson Medical Center
Tucson, Arizona, United States, 85712
Not Yet Recruiting
3
Scripps Memorial Hospital La Jolla
San Diego, California, United States, 92037
Actively Recruiting
4
UCSF
San Francisco, California, United States, 94143
Not Yet Recruiting
5
Delray Medical Center
Delray Beach, Florida, United States, 33484
Not Yet Recruiting
6
Largo Medical Center
Largo, Florida, United States, 33770
Actively Recruiting
7
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
8
Endeavor Health, Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
9
Chicago Advocate Christ
Palos Park, Illinois, United States, 60464
Not Yet Recruiting
10
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indiana, United States, 46260
Actively Recruiting
11
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
14
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
15
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
16
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Not Yet Recruiting
17
Washington University St Louis
St Louis, Missouri, United States, 63110
Not Yet Recruiting
18
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
19
North Shore University Hospital
Manhasset, New York, United States, 11030
Not Yet Recruiting
20
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
21
Duke Cardiology Clinic
Durham, North Carolina, United States, 27710
Not Yet Recruiting
22
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Actively Recruiting
23
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Not Yet Recruiting
24
Oregon Health Services
Portland, Oregon, United States, 97239
Not Yet Recruiting
25
UPMC Pinnacle
Harrisburg, Pennsylvania, United States, 17107
Actively Recruiting
26
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
27
WellSpan York Hospital
York, Pennsylvania, United States, 17403
Not Yet Recruiting
28
MUSC
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
29
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Texas (Memorial Hermann)
Houston, Texas, United States, 77030
Actively Recruiting
31
Intermountain Heart Institute - Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
32
UVA School of Medicine
Charlottesville, Virginia, United States, 22903
Actively Recruiting
33
Sentara Healthcare
Norfolk, Virginia, United States, 23507
Not Yet Recruiting
34
Carilion Clinic
Roanoke, Virginia, United States, 24014
Not Yet Recruiting
35
MedStar Washington Hospital Center
Multiple Locations, Washington, United States, 20010
Actively Recruiting
36
Swedish Medical Center
Seattle, Washington, United States, 98122
Not Yet Recruiting
Research Team
M
Monica Tocchi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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