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Acute Defibrillation Performance of a Novel Can-less Shock Pathway — NPC01PRG  

Tachycardia Clinical Trial

Official title:
Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Clinical Trial Summary

Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02941250
Study type Interventional
Source NewPace Ltd
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date April 2017
View Details
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