Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080074
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-10-06
Brief Title:
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure The main questions it aims to answer are
What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO
What are the optimal performance specifications of the Cardiohelp device in children Should the Cardiohelp device be FDA-cleared for children
Children who are receiving the Cardiohelp device will be approached and consented to participate if interested Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke bleeding and hemolysis
Outcomes will be compared to performance goals PG derived from the ECMO literature
Funding Source -- FDA OOPD Office of Orphan Product Development
What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO
What are the optimal performance specifications of the Cardiohelp device in children Should the Cardiohelp device be FDA-cleared for children
Children who are receiving the Cardiohelp device will be approached and consented to participate if interested Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke bleeding and hemolysis
Outcomes will be compared to performance goals PG derived from the ECMO literature
Funding Source -- FDA OOPD Office of Orphan Product Development
Detailed Description:
This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure Despite more than 50 years of use and significant mortality no standalone ECMO device has ever been FDA-cleared for ECMO All ECMO use in children is off-label and this may explain why there is significant center-based variation in ECMO use that is not evidence driven This study seeks to change that by collecting systematic safety and effectiveness data on a single standardized ECMO circuit Cardiohelp Device The goal is to provide the data necessary to secure FDA clearance of the first pediatric ECMO system to determine the optimal performance range of the Cardiohelp device in infants and children and to provide the FDA with a predicate device to support FDA clearance of other ECMO systems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01FD007833-01A1 | FDA | None | httpsreporternihgovquickSearch1R01FD007833-01A1 |