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Transcatheter Valve Replacement

Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

N/A
Recruiting
Led By Isaac George, MD
Research Sponsored by Trisol Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE)
New York Heart Association (NYHA) Functional Class II to IVa
Must not have
Venous anatomy unsuitable for implant delivery
Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days, 6 months and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is to test the safety and performance of a new system to treat patients with moderate or greater tricuspid regurgitation.

Who is the study for?
Adults over 18 with moderate to severe tricuspid regurgitation, who are at high risk for surgery and suitable for a non-surgical valve replacement. They must be stable on heart failure medications for at least 30 days, able to give informed consent, follow study procedures, and have the right anatomy for the Trisol system.
What is being tested?
The trial is testing the safety and performance of the Trisol system in patients with significant tricuspid valve issues. It's an early feasibility study where participants receive a transcatheter tricuspid valve replacement instead of traditional surgery.
What are the potential side effects?
Potential side effects may include bleeding due to required anticoagulation therapy, reactions related to device components or contrast media used during procedure, infection risks, and possible complications from non-surgical access through veins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate or severe symptoms from a heart valve issue, confirmed by an echo test.
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My heart condition limits my physical activity but I can still perform light tasks.
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I am older than 18 years.
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I have been treated for heart issues according to medical guidelines for at least 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My veins are not suitable for implant placement.
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I am allergic or cannot take blood thinners.
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I currently have COVID-19.
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I've had surgery on my tricuspid valve that might affect new treatments.
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I need medication or devices to help my heart pump blood.
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I have a severe narrowing of the heart's tricuspid valve.
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I have had a heart transplant or am on an urgent transplant list.
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I have a bleeding or clotting disorder.
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I do not have a non-heart related illness limiting my life to under a year.
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I have heart artery disease that hasn't been treated with surgery or procedures.
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I am currently taking antibiotics for an infection.
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I have had a heart attack in the last 3 months.
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I have a new or untreated mass or clot in my heart's right side or main upper vein.
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My heart's right ventricle is not working well.
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I need immediate surgery for a non-heart related issue.
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I am not allergic to device materials, vitamin K antagonists, or contrast media.
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I do not have an ongoing infection in my bloodstream or heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days, 6 months, 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
Change in TR from baseline
Rate of device-related serious adverse events
Rate of procedural success
+1 more
Secondary study objectives
Clinical performance endpoints - Change in NYHA class
Clinical performance endpoints - Change in TR from baseline
Clinical performance endpoints --minute walk test
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with the Trisol SystemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Trisol MedicalLead Sponsor
Isaac George, MDPrincipal InvestigatorColumbia University

Media Library

Trisol System (Transcatheter Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04905017 — N/A
Tricuspid Regurgitation Research Study Groups: Treatment with the Trisol System
Tricuspid Regurgitation Clinical Trial 2023: Trisol System Highlights & Side Effects. Trial Name: NCT04905017 — N/A
Trisol System (Transcatheter Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905017 — N/A
~0 spots leftby Jan 2025
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