Status:
COMPLETED
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Th...
Detailed 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) ...
Eligibility Criteria
Inclusion
- Approved indication for CRT-D system
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00763698
Start Date
October 1 2008
End Date
May 1 2010
Last Update
February 19 2019
Active Locations (13)
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1
University Hospital-University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
Glendale Memorial Hospital and Medical Center
Glendale, California, United States, 91204