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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-4195 Lead, 181 days | Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days |
| |
| 4195 Lead, 181 days | Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days |
| |
| 4195 Lead, 90-180 days | Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV Lead Extraction | Procedure | Removal of a LV lead using any tools & techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Removal success of LV leads implanted for more than 180 days | More than 180 days post-implant |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be chosen by investigators participating in the study at up to 25 experienced extraction centers throughout the United States and Canada. Patients of both genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria may be in the study.
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| Name | Affiliation | Role |
|---|---|---|
| 4195 Extraction Study Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| 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 |
| Burbank |
| California |
| United States |
| Long Beach | California | United States |
| Aurora | Colorado | United States |
| Miami | Florida | United States |
| Chicago | Illinois | United States |
| Kansas City | Kansas | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Saint Paul | Minnesota | United States |
| St Louis | Missouri | United States |
| Durham | North Carolina | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Plano | Texas | United States |
| Spokane | Washington | United States |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Sainte-Foy | Quebec | Canada |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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