Attain StarFix® 4195 Lead Extraction Study

Completed

• Conditions: Heart Failure; Indications for Lead Removal
• Interventions: Procedure: LV Lead Extraction

• Registration Number: NCT00893386
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-06
• Study Start: 2009-07
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-4195 Lead, 181 days	LV Lead Extraction	Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days
4195 Lead, 90-180 days	LV Lead Extraction	Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days
4195 Lead, 181 days	LV Lead Extraction	Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days

Primary Outcome Measures

Name	Time	Method
Removal success of LV leads implanted for more than 180 days	More than 180 days post-implant

Secondary Outcome Measures

Name	Time	Method
Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.	0 to 45 days post-lead extraction
Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days	90 -180 days post-implant
Success of lead removal by how long the lead has been implanted	More than 180 days post-implant
Summary of tools & techniques used to remove LV leads.	More than 180 days post-implant