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This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook lead extraction devices | The Cook lead extraction devices are indicated for use in patients requiring percutaneous removal of CIED leads, indwelling catheters and foreign objects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook lead extraction devices | Device | The Cook lead extraction devices are mechanical devices that encompass a full variety of devices required for percutaneous removal of CIED leads, indwelling catheters and foreign objects. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete procedural success | Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death. | Immediately following lead extraction |
| Rate of clinical procedural success | Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure. | Immediately following lead extraction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring percutaneous removal of Cardiovascular Implantable Electronic Device (CIED) leads
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94143 | United States | ||
| Carle Foundation |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| Urbana |
| Illinois |
| 61801 |
| United States |
| NC Heart and Vascular Reseach | Raleigh | North Carolina | 27607 | United States |
| Wellspan York Hospital | York | Pennsylvania | 17403 | United States |
| Memorial Hermann | Houston | Texas | 77030 | United States |
| University of VA Medical Center | Charlottesville | Virginia | 22908 | United States |
| German Heart Center Berlin | Berlin | Germany |
| Isala | Zwolle | Netherlands |
| St. George's University Hospital | London | SW17 0QT | United Kingdom |