Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-16
Brief Title:
Cardiac Simulator for Surgical Planning
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 clinical trial is to learn if a computer software program cardiac simulator for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease It is not a commercially available device to treat congenital heart disease in pediatric patients The main aims are
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator
To aid surgeons in envisioning different surgical approaches for each individual patient
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique complex congenital heart disease
Participants will
Consent to being randomized with a 50 chance of receiving standard of care on the fly surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator
To aid surgeons in envisioning different surgical approaches for each individual patient
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique complex congenital heart disease
Participants will
Consent to being randomized with a 50 chance of receiving standard of care on the fly surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group
Detailed Description:
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL173845-01 | NIH | NIH | httpsreporternihgovquickSearch1R01HL173845-01 |