Trials / Completed
CompletedNCT01179477
QuickFlex Micro Left Ventricular Lead Post Approval Study
QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,930 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
Detailed description
The primary endpoints of the study are: * Freedom from LV lead-related complications at 5 years * LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of a QuickFlex® μ Model 1258T LV Lead | Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2010-08-11
- Last updated
- 2019-08-12
- Results posted
- 2019-08-12
Locations
77 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01179477. Inclusion in this directory is not an endorsement.