Authors
St. Jude Medical Inc.
Title
Summary of Safety and Effectiveness Data. Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. St. Jude Medical Epic HF System including the Epic HF Model V-338 cardiac resynchronization therapy defibrillator, the Aescula LV model 1055K lead, the QuickSite LV model 1056K lead, and the model 3307, v4.5m programmer software.
References
US Food and Drug Administration. Premarket Approval Application Number: P030054. Available at: accessdata.fda.gov
Background
None.
Purpose
To determine the safety and effectiveness of the QuickSite LV lead system in an ICD indicated patient population with advanced heart failure and prolonged QRS duration.
Design
Prospective, multi-center trial 162 patients enrolled Approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia NYHA III/IV despite optimal pharmacological therapy LVEF ≤ 35% QRS ≥ 130 ms
Exclusion Criteria
NYHA I/II Contraindication for an emergency thoracotomy Hypersensitivity to single 1.0 mg dose of dexamethasone sodium phosphate Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months Recent MI, unstable angina, or PTCA/PCI/CABG within 30 days of enrollment Currently participating in a clinical investigation that includes an active treatment arm Pregnant or planning for pregnancy in the next 6 months Life expectancy of less than 6 months Less than 18 years of age
Follow-Up
Not specified.
Treatment Regimen
Implantation of ICD/CRT system with LV lead Evaluation at baseline, 1 month, 3 months, and subsequently every 6 months until study completion
Results
Primary End Points: LV lead-related complications: Survival at 3 months from complications 96.1% (one-sided 95% lower confidence interval of 93.5%) Quicksite LV lead implant success: 94.4% (one-sided 95% lower confidence interval of 90.5%) Quicksite LV lead pacing capture threshold at 6 months: Average 1.6 ± 1.4 V (one-sided 95% upper confidence interval 1.81 V)
Summary
CRT with the Quicksite LV lead demonstrated an acceptable device safety profile.