QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2010 |
| End Date: | March 2017 |
| Contact: | Jasmina Halilovic |
| Email: | jhalilovic@sjm.com |
The purpose of this multicenter post-approval study is to evaluate the acute and chronic
performance of the QuickFlex® μ 1258T left ventricular lead.
The endpoints of the study are:
- Complication free survival rate at 5 years for complications related to the LV lead
- Electrical performance (capture threshold) of St. Jude Medical's QuickFlex®µ 1258T LV
Lead
Inclusion Criteria:
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D
system or participated in the QuickFlex® μ1258T IDE study
- Have the ability to provide informed consent for study participation and be willing
and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or
short term contact with heparin
- Have a life expectancy of less than 5 years due to any condition
- Be less than 18 years of age
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