Attain StarFix® 4195 Lead Extraction Study

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2009
End Date:	April 2015

Attain StarFix® Model 4195 LV Lead Extraction Study

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.

Inclusion Criteria:

- Subjects with a Class I/II indication and/or physician discretion for left
ventricular lead removal

- Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction,
or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time
of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days

- Intention to remove the LV lead prior to the extraction procedure

- Subject is 18 years of age or older

- Subject (or subject's legally authorized representative) has signed and dated the
Patient Consent Form and is willing and able to comply with the protocol

Exclusion Criteria:

We found this trial at

sites

Clinical Trial Facility in Phoenix Arizona

Phoenix, Arizona

from

Phoenix, AZ