Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-27 @ 6:51 AM
Study NCT ID:
NCT05490459
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2022-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Jewel Electrophysiology (EP) Lab Study
Sponsor:
Element Science, Inc.
Organization:
Study Overview
Official Title:
Jewel Electrophysiology (EP) Lab Study
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
Detailed Description:
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
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?: