Attain StarFix® 4195 Lead Extraction Study

Medtronic Cardiac Rhythm and Heart Failure227 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

227

Conditions

Heart Failure Indications for Lead Removal

Interventions

LV Lead ExtractionPROCEDURE

Removal of a LV lead using any tools \& techniques.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Burbank, California, United States

Outcomes

Primary Outcomes

Removal success of LV leads implanted for more than 180 days

Time frame: More than 180 days post-implant

Secondary Outcomes

Success of lead removal by how long the lead has been implanted

Time frame: More than 180 days post-implant

Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.

Time frame: 0 to 45 days post-lead extraction

Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days

Time frame: 90 -180 days post-implant

Summary of tools & techniques used to remove LV leads.

Time frame: More than 180 days post-implant

Data from ClinicalTrials.gov

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