Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | October 2008 |
| End Date: | May 2010 |
QuickFlex Micro Model 1258T Left Heart Pacing Lead
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.
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.
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.
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.
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
We found this trial at
13
sites
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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