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Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

Heart Failure Clinical Trial

Official title:
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study

Clinical Trial Summary

The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

Clinical Trial Description

This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.

A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.

All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02548455
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date October 27, 2015
Completion date March 21, 2017
View Details
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