Clinical Trial Details

Overview

Research Study Summary

“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

Purpose

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.

To Learn more

CW ID: 216030
Date Last Changed: June 10, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
St. Jude Medical
Duration
24 Months
Facility Type
N/A

Eligibility

Inclusion:
To participate in this clinical study, the subject must meet all of the following inclusion criteria:
  • Meets current SJM clinical indication for implantation of a CRT system:
    to provide a reduction of the symptoms of moderate to severe heart failure »(NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤35% and a prolonged QRS duration or to maintain synchrony of the left and right ventricles in patients who have »undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure (PAVE)
  • Receiving a new market-approved SJM Quadripolar CRT system implant with the Model 1457Q Quartet LV lead
  • Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  • Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion:
Subjects are not eligible for clinical study participation if they meet any of the following exclusion criteria:
  • Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  • Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
  • Are pregnant or planning pregnancy in the next 6 months
  • Have a life expectancy of less than 24 months due to any condition

More Info

The primary objective of this study is to assess the safety of the Quartet 1457Q lead in a clinical setting from implant through 3 months (91 days) of follow up.

Contact

Feather Wafford, Baptist Health Lexington Research Regulatory Coordinator
Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
1740 Nicholasville Rd
Lexington, KY 40503
Phone: 859-260-6066
Fax: 859-260-4151

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