Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
Study NCT ID:
NCT04132466
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2019-10-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
Sponsor:
Kestra Medical Technologies, Inc.
Organization:
Study Overview
Official Title:
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
Status:
COMPLETED
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:
ACE-CONVERT
Brief Summary:
A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
Detailed Description:
The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.
Study Oversight
Has Oversight DMC:
False
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?: