Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-28 @ 7:31 PM
Study NCT ID:
NCT04118803
Status:
UNKNOWN
Last Update Posted:
2023-06-05
First Post:
2019-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Inappropriate Therapies
Sponsor:
MicroPort CRM
Organization:
Study Overview
Official Title:
Observational Study on Inappropriate Therapies After Replacement of ICDs
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
OSIRIS
Brief Summary:
The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
Detailed Description:
All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring.
Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system.
All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness.
The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).
Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system.
All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness.
The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).
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?: