Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
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.
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
Sites / Locations
- Heart Center Research
- Arizona Arrhythmia Research Center
- Cardiology Associates of Northeast Arkansas
- Scripps Health
- Premier Cardiology, Inc.
- Stanford University Hospital
- Munroe Regional Medical Center
- Tallahassee Research Institute
- Emory University Hospital
- North Georgia Heart Foundation
- Iowa Heart Center
- Central Baptist Hospital
- One Health Cardiology
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Thoracic Cardiovascular Healthcare Foundation
- Missouri Heart Center
- Catholic Medical Center
- Cardiovascular Associates of Delaware Valley
- Forsyth Medical Center
- University Hospitals of Cleveland
- Oklahoma Heart Institute at Utica
- Lancaster General Hospital
- Donald Guthrie Foundation for Education & Research
- Greenville Health System
- Erlanger Medical Center
- The Stern Cardiovascular Foundation
- The Heart Hospital Baylor Plano
- Swedish Medical Center - Heart & Vascular
- St. Mary's Hospital
Arms of the Study
Arm 1
Experimental
Treatment
Subjects implanted with the Quartet 1457Q LV lead