N/A
Completed N=1,930
QuickFlex Micro Left Ventricular Lead Post Approval Study
Source: ClinicalTrials.gov NCT01179477 ↗Enrolled (actual)
1,930
Serious AEs
13.4%
Results posted
Aug 2019
Primary outcomePrimary: Percent of Participants Alive and Without a Left Ventricular Lead-related Complication — 1902 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Alive and Without a Left Ventricular Lead-related Complication |
1902 | — |
| PRIMARY Left Ventricular Bipolar Pacing Capture Threshold |
2.04 | — |
Eligibility Criteria
Inclusion Criteria
- Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (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
Data sourced from ClinicalTrials.gov (NCT01179477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.