Last updated on November 2017

“A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study" Quartet 1457Q IDE


Brief description of study

“A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study" Quartet 1457Q IDE

Detailed Study Description

Heart failure (HF) is a major threat to public health affecting 5.8 million individuals in the United States (U.S.). It is estimated that one in five people who have heart failure die within one year from diagnosis1. Several randomized clinical trials have demonstrated the benefits of heart failure patients receiving cardiac resynchronization therapy (CRT) with an implantable cardioverter defibrillator2,3,4,5.

During implantation of a CRT device, many challenges, such as elevated thresholds and diaphragmatic stimulation, can arise. These challenges can also occur during follow up visits necessitating surgical intervention. Increasing the number of pacing configurations can help decrease the number of lead repositions.6 St. Jude Medical has a new family of quadripolar left heart leads that provide up to fourteen different pacing configurations, one of which is the Quartet 1457Q lead.

The Quartet™ Model 1457Q left ventricular (LV) heart lead with any SJM market approved SJM CRT-P or CRT-D device with quadripolar pacing capabilities, hereafter referred to as the Quadripolar CRT system, provides vector selection (Vect Select™) from four pacing electrodes on the left ventricular (LV) lead. Using four pacing electrodes, up to fourteen different pacing configurations are available with the Merlin PCS programmer. The primary benefit of these fourteen vectors is the programmability and flexibility to optimize capture thresholds. The Quadripolar CRT system is comprised of the following:

  • A device with an IS4 compatible LV lead port
  • An IS4 compatible LV lead that has four independent pacing electrodes
  • A Merlin PCS programmer with applicable software that allows up to fourteen different pacing configurations.

In a premarket IDE clinical trial, the Quartet™ Model 1458Q left ventricular heart lead, on which the Quartet 1457Q lead design is based, was successfully implanted in a high percentage of patients, had clinically acceptable bipolar electrical performance, and demonstrated an acceptable safety profile (PMA application number P030054/S173).

The goal of this IDE is to assess the safety of Quartet 1457Q lead in a clinical setting.

Clinical Study Identifier: TX8471

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Feather Wafford

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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