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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT02548455

Run by

Abbott Medical Devices

People needed

499

Starts

2015-10-27

Expected to finish

2017-03-21

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
• " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association 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 Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
• Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q 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.

You may not qualify if…

• 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

Where it is running

• Heart Center Research — Huntsville, Alabama, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
• Scripps Health — La Jolla, California, United States
• Premier Cardiology, Inc. — Newport Beach, California, United States
• Stanford University Hospital — Stanford, California, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• North Georgia Heart Foundation — Gainesville, Georgia, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• One Health Cardiology — Owensboro, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Thoracic Cardiovascular Healthcare Foundation — Lansing, Michigan, United States
• Missouri Heart Center — Columbia, Missouri, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Cardiovascular Associates of Delaware Valley — Haddon Heights, New Jersey, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Oklahoma Heart Institute at Utica — Tulsa, Oklahoma, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Donald Guthrie Foundation for Education & Research — Sayre, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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