Attain StarFix® 4195 Lead Extraction Study

Study Overview
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Brief Summary
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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.

Official Title
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Attain StarFix® Model 4195 LV Lead Extraction Study

Conditions
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Heart Failure, Indications for Lead Removal

Intervention / Treatment
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* Procedure: LV Lead Extraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-4195 Lead, 181 days<br>Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days | Procedure: LV Lead Extraction<br>* Removal of a LV lead using any tools & techniques.<br>|
| 4195 Lead, 181 days<br>Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days | Procedure: LV Lead Extraction<br>* Removal of a LV lead using any tools & techniques.<br>|
| 4195 Lead, 90-180 days<br>Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days | Procedure: LV Lead Extraction<br>* Removal of a LV lead using any tools & techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal success of LV leads implanted for more than 180 days |  | More than 180 days post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extraction, Removal, Lead, Heart Failure