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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days, 6 months and 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 days, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in TR from baseline
Rate of device-related serious adverse events
Rate of procedural success
+1 moreSecondary outcome measures
Clinical performance endpoints - Change in NYHA class
Clinical performance endpoints - Change in TR from baseline
Clinical performance endpoints --minute walk test
+1 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure in the arteries of your lungs is higher than 80 mmHg when measured with a special device.My veins are not suitable for implant placement.I am allergic or cannot take blood thinners.You have a pacemaker or ICD lead that could interfere with the placement of the valve.I am of legal age to make my own health decisions.I currently have COVID-19.I have moderate or severe symptoms from a heart valve issue, confirmed by an echo test.I've had surgery on my tricuspid valve that might affect new treatments.I need medication or devices to help my heart pump blood.I haven't had any serious stomach or intestine bleeding in the last 2 months.I am considered high risk for tricuspid valve surgery and suitable for a less invasive valve replacement.I have had or need surgery for a severe heart valve problem within the last 3 months.I have a severe narrowing of the heart's tricuspid valve.My heart condition limits my physical activity but I can still perform light tasks.I have had a heart transplant or am on an urgent transplant list.I have not had a heart device implant or revision in the last 30 days.I have a bleeding or clotting disorder.My heart's pumping ability is very low.I am older than 18 years.I do not have a non-heart related illness limiting my life to under a year.I am a man or a woman not currently pregnant.I have not had a stroke or mini-stroke in the last 3 months.I have heart artery disease that hasn't been treated with surgery or procedures.I am currently taking antibiotics for an infection.I have had a heart attack in the last 3 months.I have a new or untreated mass or clot in my heart's right side or main upper vein.I haven't had any heart or carotid artery surgeries in the last 30 days.My heart's right ventricle is not working well.You have a low white blood cell count (less than 3000 cells/mm3) or a low platelet count (less than 50,000 cells/mm3).I need immediate surgery for a non-heart related issue.I am not allergic to device materials, vitamin K antagonists, or contrast media.I have been treated for heart issues according to medical guidelines for at least 30 days.I am willing and able to follow the study's requirements.I do not have an ongoing infection in my bloodstream or heart.You cannot have a transesophageal echocardiogram.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with the Trisol System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the projected result from this experiment?
"This medical trial, which is expected to last for up to 30 days, will evaluate a Change in TR from baseline. Additional secondary outcomes that are being measured include an alteration in NYHA class based on data collected by the New york Heart Association (NYHA), a reduction of TR grade as compared to baseline TTE imaging results, and Quality-of-Life changes according to Kansas City Cardiomyopathy Questionnaire scores."
Answered by AI
Are there opportunities for prospective participants to join the clinical trial?
"According to clinicaltrials.gov, this trial is no longer accepting applicants since its initial posting on November 1st 2021 and last edit occurring one day later. However, there are 40 other studies searching for participants at the moment."
Answered by AI
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