Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:55 PM
Study NCT ID:
NCT00717106
Status:
UNKNOWN
Last Update Posted:
2009-05-05
First Post:
2008-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Sleuth Implantable ECG Monitoring System
Sponsor:
Transoma Medical
Organization:
Study Overview
Official Title:
Observational Study of the Sleuth Implantable ECG Monitoring System
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
ENROLLING_BY_INVITATION
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:
OBSERV-ECG
Brief Summary:
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: