Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06358105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
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:
STARTERS
Brief Summary:
The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.
The main questions it aims to answer are:
* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?
Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
The main questions it aims to answer are:
* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?
Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: