Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05062434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2021-09-09
Brief Title:
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans CDA 21-057
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Veteran CIEDs
Brief Summary:
This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator ICD lead models implanted in Veterans
Detailed Description:
This study will identify Department of Veterans Affairs VA-based cardiac electrophysiologists at three Veterans Integrated Service Networks VISNs Each cardiac electrophysiologist will participate in a videoconference during which time an academic detailing and audit and feedback intervention will be implemented which will include details and recommendations about lead selection for implantation based on cardiovascular implantable electronic device CIED pacemaker and implantable cardioverter-defibrillator ICD lead-specific failure rates for lead models currently available in clinical practice The cardiac electrophysiologist will also be presented with quantitative data about the individual physicians facilitys implants and national data on implants over the past year These data will be shared in advance with time for questions and discussion The electrophysiologist will be asked if anything can be done to facilitate selection of CIED lead models with the statistically and clinically significantly lower failure rates
Then over the subsequent 3 months a quantitative evaluation of the CIED lead models implanted will be evaluated comparing changes in lead model selection among the electrophysiologists receiving the intervention to a control group of all VA cardiac electrophysiologists who do not receive the intervention Subsequently semi-structured interviews will be conducted to assess reasons for changes or lack thereof in CIED lead model selection - including barriers and facilitators Finally quantitative data will be included to each of the cardiac electrophysiologists with additional feedback
Then over the subsequent 3 months a quantitative evaluation of the CIED lead models implanted will be evaluated comparing changes in lead model selection among the electrophysiologists receiving the intervention to a control group of all VA cardiac electrophysiologists who do not receive the intervention Subsequently semi-structured interviews will be conducted to assess reasons for changes or lack thereof in CIED lead model selection - including barriers and facilitators Finally quantitative data will be included to each of the cardiac electrophysiologists with additional feedback
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1IK2HX003357-01A1 | NIH | None | httpsreporternihgovquickSearch1IK2HX003357-01A1 |