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Tests treatment safety and results for HLH - Hypoplastic Left Heart Syndrome
Official title Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
ClinicalTrials.gov ID: NCT04467671
What this study is testing
What is Tissue Engineered Vascular Grafts?
Tissue Engineered Vascular Grafts is an investigational medicine, being studied as a potential treatment for hlh - hypoplastic left heart syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients will be eligible for inclusion in the study if they meet all of the following criteria.
- Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
- Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.
You likely can't join if
- Patients will be excluded from participation in the study if they meet any of the following criteria.
- Patient has an urgent/emergent operative status.
- Patient has acute renal failure or renal insufficiency in the opinion of the investigator
- Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
- Patient has a pacemaker.
- Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
See the full eligibility criteria
- Patients will be eligible for inclusion in the study if they meet all of the following criteria.
- Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
- Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.
- Patients will be excluded from participation in the study if they meet any of the following criteria.
- Patient has an urgent/emergent operative status.
- Patient has acute renal failure or renal insufficiency in the opinion of the investigator
- Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
- Patient has a pacemaker.
- Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
- Patient has abnormal venous drainage (interrupted inferior vena cava [IVC]).
- Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.
- Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.
- Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).
- Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.
- Preoperative hemoglobin \<11.0 mg/dL at time of patient's pre-admission testing.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.