Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342999
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2024-03-27
Brief Title:
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Sponsor:
Mauro H Schenone
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluation of Outcomes of Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome HLHS
Detailed Description:
The condition occurs when part of the heart doesnt develop properly so the heart is not able to pump blood around the body effectively Babies born with this condition require surgery and are often left with a lifelong heart disability A number of babies with this condition will die during pregnancy or within the first year of life approximately 10-40 We are investigating a treatment given during pregnancy in which a balloon is used to increase the size of the babys aortic valve The aortic valve function is to allow easy flow from the heart to the body and prevent blood from returning to the heart regurgitation This is called fetal aortic valvuloplasty A number of studies have shown promising results including a higher of the baby surviving with both sides of the heart functioning as opposed to only the right side this may also lead to longer survival with a better quality of life However we do not have enough information to say this is always the best way to manage the condition Currently parents of babies with this condition who meet certain eligibility criteria are offered fetal aortic valvuloplasty during pregnancy The alternative option is not to intervene during pregnancy but instead monitor the baby with regular ultrasounds We call this conservative management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None