Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
Status
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Details and patient eligibility
About
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
Full description
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Approved indication for CRT-D system
Exclusion criteria
- Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Previous left ventricular (LV) lead implant
- Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment
Trial design
Primary purpose
Allocation
Interventional model
Masking
86 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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