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Bioprosthesis

TricValve System for Tricuspid Valve Disease (TRICAV-II Trial)

N/A
Waitlist Available
Research Sponsored by P+F Products + Features USA Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be 18 years or older
Severe tricuspid regurgitation (TR), as determined by Echo Core Lab
Must not have
Severe right ventricular dysfunction
Cardiac amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new device called the TricValve Transcatheter Bicaval Valve System, which comes in two sizes for each model to fit the vena cava. The

Who is the study for?
This trial is for individuals with severe tricuspid valve disease, specifically those suffering from tricuspid regurgitation. Participants should be experiencing symptoms that significantly impact their daily life or have a high risk of complications from surgery.
What is being tested?
The study tests the TricValve Transcatheter Bicaval Valve System against optimal medical therapy. The system includes two bovine pericardium leaflet valves mounted on self-expanding stents, inserted via veins in the leg to reach and support the heart's tricuspid valve without disturbing it.
What are the potential side effects?
Potential side effects may include bleeding or bruising at the insertion site, infection, damage to blood vessels, irregular heart rhythms, or improper placement of the device leading to valve dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My heart has a severe valve issue confirmed by an echo test.
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I have severe heart issues or was hospitalized for heart failure recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's right side is very weak.
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I have been diagnosed with cardiac amyloidosis.
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I have a narrowed heart valve.
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My heart failure is severe and needs advanced treatment.
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My liver disease is severe.
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My kidney function is very low or I am on dialysis.
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I have an ongoing infection or endocarditis needing antibiotics.
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I cannot walk 60 meters in 6 minutes.
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I have a serious heart condition present from birth.
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I haven't had a heart attack, stroke, or major heart surgery in the last 3 months.
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I need another major heart surgery.
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I have a serious fluid buildup around my heart.
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I cannot tolerate blood thinners.
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I have not had severe heart issues or needed heart support devices in the last 30 days.
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I have a bleeding or clotting disorder, or I refuse blood transfusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disabling stroke
Emergency surgery or intervention related to the device/procedure complications
Heart Failure Events
+9 more
Secondary study objectives
All-Cause mortality
Atrial Fibrillation
Kansas City Cardiomyopathy Questionnaire (KCCQ Score)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TricValve® Device (Device) + Optimal medical therapy (OMT)Experimental Treatment2 Interventions
TricValve® Device (Device) + OMT
Group II: TricValve Single Arm RegistryExperimental Treatment2 Interventions
Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.
Group III: Optimal medical therapy (OMT) AloneActive Control1 Intervention
OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optimal medical therapy
2015
Completed Phase 4
~760

Find a Location

Who is running the clinical trial?

P+F Products + Features USA Inc.Lead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Meditrial USA Inc.Industry Sponsor
8 Previous Clinical Trials
1,450 Total Patients Enrolled
~400 spots leftby Dec 2025
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