Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-31 @ 11:17 PM
Study NCT ID:
NCT03093051
Status:
TERMINATED
Last Update Posted:
2022-10-10
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unpinning Termination Therapy for VT (US)
Sponsor:
Cardialen, Inc.
Organization:
Study Overview
Official Title:
A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor ceased operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
Detailed Description:
This non-blinded, single-arm open-label, phase 1 pilot, acute research feasibility trial aims to demonstrate that the safety and effectiveness of Unpinning Termination (UPT) electrotherapy observed in the canine can be translated to humans and to demonstrate the safety and performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia (VT) catheter ablation or an indicated initial implant or device replacement of an implantable cardioverter defibrillator (ICD).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R44HL107055-02 | NIH | None | https://reporter.nih.gov/quic… | View |