Trials / Completed
CompletedNCT00893386
Attain StarFix® 4195 Lead Extraction Study
Attain StarFix® Model 4195 LV Lead Extraction Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 227 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | LV Lead Extraction | Removal of a LV lead using any tools \& techniques. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2009-05-06
- Last updated
- 2016-02-01
Locations
24 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00893386. Inclusion in this directory is not an endorsement.