Attain StarFix® 4195 Lead Extraction Study
NCT00893386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 227
Last updated 2016-02-01
Summary
The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.
Conditions
- Heart Failure
- Indications for Lead Removal
Interventions
- PROCEDURE
-
LV Lead Extraction
Removal of a LV lead using any tools \& techniques.
Sponsors & Collaborators
-
Medtronic Cardiac Rhythm and Heart Failure
lead INDUSTRY
Principal Investigators
-
4195 Extraction Study Team · Medtronic
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
- Canada
Study Locations
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