Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-14 @ 2:27 PM
Study NCT ID:
NCT05049720
Status:
WITHDRAWN
Last Update Posted:
2022-09-10
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ExtraVascular Implantable Cardiac Defibrillator Continued Access Study
Sponsor:
Medtronic
Organization:
Study Overview
Official Title:
ExtraVascular Implantable Cardiac Defibrillator Continued Access Study
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The NCT posting for the study has been transferred to NCT04060680
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EV ICD CA
Brief Summary:
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Detailed Description:
The study will enroll subjects who are indicated to receive an implantable defibrillator who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed every 6 months following system implantation.
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?: