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
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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