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Tissue Engineered Vascular Grafts for Heart Disease (TEVG-2 Trial)
TEVG-2 Trial Summary
This trial is testing a new type of surgery for people with heart problems. The new surgery is called "extracardiac total cavopulmonary connection." This trial is testing to see if the new surgery is safe and if it works well.
TEVG-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEVG-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEVG-2 Trial Design
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Who is running the clinical trial?
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- You need a graft that is not between 12 and 24 millimeters in diameter.I have kidney problems as determined by my doctor.My heart valve leakage is severe, making me ineligible.Your blood vessels in the lungs have high resistance.I am not on medications like bisphosphonates that could affect the trial.I am eligible for a specific heart surgery to improve blood flow.My veins that return blood to my heart are not normal.I need surgery urgently or as an emergency.Your hemoglobin levels are less than 11.0 mg/dL before surgery.
- Group 1: Tissue Engineered Vascular Grafts
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any remaining vacancies for patients in this clinical trial?
"That is correct. The clinical trial described on clinicaltrials.gov appears to be actively recruiting patients at the moment. This specific study was posted on 7/15/2020, and updated as recently as 8/4/2022. They are hoping to enroll 24 total patients from 1 site."
How many people are being given the chance to participate in this research?
"Yes, as of 8/4/2022 this trial is still recruiting patients that meet the requirements. Originally posted on 7/15/2020, the study needs 24 more participants from 1 site."
Has the FDA cleared Tissue Engineered Vascular Grafts for use?
"Tissue Engineered Vascular Grafts have only been proven safe in Phase 2 trials, so they received a score of 2."
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