Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-02 @ 10:05 AM
Study NCT ID:
NCT02941250
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2016-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Defibrillation Performance of a Novel Can-less Shock Pathway
Sponsor:
NewPace Ltd
Organization:
Study Overview
Official Title:
Acute Defibrillation Performance of a Novel Can-less Shock Pathway
Status:
COMPLETED
Status Verified Date:
2016-10
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:
NPC01PRG
Brief Summary:
Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.
Detailed Description:
The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed.
The emulator is not a powered medical device.
This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.
The emulator is not a powered medical device.
This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.
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?: