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Procedure

TricValve System for Tricuspid Regurgitation (TRICAV 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

NYHA Class 3-4 (not on inotropes) OR HF admission in the past 6 months

Subject must be 18 years or older, at the time of signing the informed consent

Must not have

Unable to take Coumadin or Direct Oral Anticoagulants (DOAC)

Tricuspid stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial implantation system enables a minimally-invasive tricuspid valve replacement through percutaneous access and delivery to the inferior and superior vena cava.

Who is the study for?

This trial is for adults over 18 with severe tricuspid valve disease, specifically regurgitation, who have been stable on heart failure medication for at least 30 days. They should be high risk for surgery and not candidates for other approved transcatheter devices. Exclusions include those with very weak hearts (LVEF ≤30%), recent strokes, or need other heart procedures soon.

What is being tested?

The TricValve® Transcatheter Bicaval Valve System is being tested against standard medical therapy. This device involves placing two valves via a vein to help the heart's right side function better without disturbing the existing tricuspid valve.

What are the potential side effects?

Potential side effects may include complications from inserting the device such as bleeding or infection, issues related to the bovine material of the valve like allergic reactions, and possible blood clots despite taking anticoagulants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe heart issues but am not on strong heart medications, or I was hospitalized for heart failure in the last 6 months.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take Coumadin or any direct oral anticoagulants.

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I have a narrowed tricuspid heart valve.

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I have a blood clot in my leg veins or an IVC filter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Emergency surgery or intervention related to the device/procedure complications

Heart Failure Events

Major vascular, access-related, or cardiac structural complication

+6 more

Secondary study objectives

Device success within 30 days after device placement

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

Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

+7 more