Attain StarFix® 4195 Lead Extraction Study

Attain StarFix® Model 4195 LV Lead Extraction Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00893386

Enrollment

227

Registered

2009-05-06

Start date

2009-07-31

Completion date

2015-04-30

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Indications for Lead Removal

Keywords

Extraction, Removal, Lead, 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.

Interventions

PROCEDURELV Lead Extraction

Removal of a LV lead using any tools & techniques.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* None

Design outcomes

Primary

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

Secondary

Measure	Time frame
Success of lead removal by how long the lead has been implanted	More than 180 days post-implant
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
Summary of tools & techniques used to remove LV leads.	More than 180 days post-implant

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026