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Polymer Aortic Valve
Foldax Tria Aortic Valve Replacement for Aortic Valve Disease
N/A
Waitlist Available
Led By Frank Shannon, MD
Research Sponsored by Foldax, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is 18 years or older
Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years following patient enrollment
Awards & highlights
Study Summary
This trial is testing a new aortic valve to see if it is safe and effective. The goal is to show that it is better than the current standard valve.
Who is the study for?
This trial is for adults needing aortic valve replacement due to symptomatic aortic valve disease. Participants must consent to follow-up for 5 years and have no recent strokes, life expectancy under 12 months, multiple valve issues, emergency surgery needs, prior valve surgeries, or other exclusions like severe kidney problems.Check my eligibility
What is being tested?
The Foldax Tria Aortic Valve is being tested in this study. It aims to evaluate the safety and performance of this new heart valve device by monitoring improvements in how well blood flows through it after implantation.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include bleeding, infection at the incision site, irregular heart rhythms or potential complications related to heart valve replacements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with a heart valve problem and advised to have it replaced.
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I have agreed in writing to participate in the trial after being advised I need an aortic valve replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years following patient enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years following patient enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint: Hemodynamic Performance Assessment
Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment
Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments
+1 moreSecondary outcome measures
Secondary Endpoint: Change in Quality of Life (QOL)
Secondary Endpoint: Hemolysis screen
Secondary Endpoint: ICU Duration of Stay
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tria Aortic ValveExperimental Treatment1 Intervention
Patients receiving the Foldax Tria Aortic Valve
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Who is running the clinical trial?
Foldax, IncLead Sponsor
3 Previous Clinical Trials
135 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
50 Patients Enrolled for Aortic Valve Disease
Frank Shannon, MDPrincipal InvestigatorBeaumont Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery that is not related to my heart.I've had a stroke or mini-stroke confirmed by MRI or CT scan in the last 3 months.You are expected to live for less than 12 months.I need a device to help my heart pump blood.I am 18 years old or older.I need a heart procedure that is not a bypass or root enlargement.My kidney function is low or I am on chronic dialysis.I have been diagnosed with HOCM, not just muscle thickening found during surgery.I have been diagnosed with a heart valve problem and advised to have it replaced.I need surgery to fix or replace more than one heart valve.I have agreed in writing to participate in the trial after being advised I need an aortic valve replacement.I have had heart valve surgery before.I am planning to have surgery not related to the study within the next year.I have had an organ transplant or am waiting for one.You currently have COVID-19.Your heart's pumping function is very low, as shown in an ultrasound test.I have been diagnosed with abnormal calcium levels or hyperparathyroidism.I have not had heart inflammation in the last 3 months.I need emergency surgery.You have a blood clot or growth inside your heart as shown by an ultrasound test.I had a heart attack within the last 30 days before my planned valve surgery.I haven't needed heart or lung support machines in the last 30 days.I have low white blood cell count, anemia, low platelets, or a bleeding/clotting disorder.You have a record of using drugs or drinking heavily in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Tria Aortic Valve
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.
Has the enrollment process for this clinical trial already begun?
"According to clinicaltrials.gov, this particular study is not currently open for recruitment. Initially posted on June 18th 2019 and last updated February 24th 2022, it is now closed - however, 180 other active trials are seeking participants at the moment."
Answered by AI
What outcomes is this clinical trial attempting to achieve?
"According to the study's sponsor, Foldax Inc., they will be measuring primary outcome of hemodynamic performance over 12 months. They are also evaluating secondary outcomes such as new onset atrial fibrillation (confirmed on ECG), length of stay in ICU post-implantation, and patient readmission rate after initial discharge."
Answered by AI
How many medical facilities are actively conducting this research?
"The 5 locales hosting this medical trial consist of OhioHealth Riverside in Columbus, The Christ Hospital located at Cincinnati and Ascension Via Christi St. Francis Hospital in Wichita among others."
Answered by AI
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