NCT03093051

Unpinning Termination Therapy for VT (US)

A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cardialen, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Unpinning Termination therapy	Electrotherapy comprised of standard biphasic and monophasic pacing pulses

Timeline

• Start date: 2019-04-08
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2017-03-28
• Last updated: 2022-10-10

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study