Attain StarFix® 4195 Lead Extraction Study

Medtronic

Status

Completed

Conditions

Indications for Lead Removal

Heart Failure

Treatments

Procedure: LV Lead Extraction

Study type

Observational

Funder types

Industry

Identifiers

NCT00893386

StarFix Extraction

Details and patient eligibility

About

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.

Enrollment

227 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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