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Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attain Performa™ LV Leads | Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lead complication | Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study. Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Types of lead-related adverse device effects | Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure. |
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Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria
Exclusion Criteria
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Patients implanted with an Attain Performa™ LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| 5 years |
| Returned lead analysis | A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported. | 5 years |
| Lead survival estimate by model | An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model. | 5 years |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Chandler | Arizona | 85226 | United States |
| Gilbert | Arizona | 85295 | United States |
| Jonesboro | Arkansas | 72410 | United States |
| Bakersfield | California | 93301 | United States |
| Rancho Mirage | California | 92270 | United States |
| Redwood City | California | 94062 | United States |
| Salinas | California | 93901 | United States |
| San Diego | California | 92103 | United States |
| Stanford | California | 94305 | United States |
| Torrance | California | 90503 | United States |
| Van Nuys | California | 91405 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Lakewood | Colorado | 80228 | United States |
| New Haven | Connecticut | 06519 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Bradenton | Florida | 34205 | United States |
| Clearwater | Florida | 33756 | United States |
| Jacksonville | Florida | 32216 | United States |
| Safety Harbor | Florida | 34695 | United States |
| Albany | Georgia | 31701 | United States |
| Marietta | Georgia | 30060 | United States |
| Evansville | Indiana | 47710 | United States |
| West Des Moines | Iowa | 50266 | United States |
| Kansas City | Kansas | 66160 | United States |
| Edgewood | Kentucky | 41017 | United States |
| Lexington | Kentucky | 40503 | United States |
| Louisville | Kentucky | 40207 | United States |
| Baton Rouge | Louisiana | 70808 | United States |
| Hyattsville | Maryland | 20782 | United States |
| Salisbury | Maryland | 21804 | United States |
| Silver Spring | Maryland | 20910 | United States |
| Takoma Park | Maryland | 20912 | United States |
| Lansing | Michigan | 48912 | United States |
| Marquette | Michigan | 49855 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Minneapolis | Minnesota | 55407 | United States |
| Robbinsdale | Minnesota | 55422 | United States |
| Rochester | Minnesota | 554905 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | United States |
| Columbia | Missouri | 65201 | United States |
| Kansas City | Missouri | 64111 | United States |
| St Louis | Missouri | 63110 | United States |
| Las Vegas | Nevada | 89169 | United States |
| Lebanon | New Hampshire | 03766 | United States |
| Morristown | New Jersey | 07960 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Huntington | New York | 11743 | United States |
| New York | New York | 10032 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Utica | New York | 13501 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27705 | United States |
| Raleigh | North Carolina | 27610 | United States |
| Akron | Ohio | 44304 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44195 | United States |
| Toledo | Ohio | 43608 | United States |
| Portland | Oregon | 97220 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| St Luke's University Health Network | Bethlehem | Pennsylvania | United States |
| Danville | Pennsylvania | 17822 | United States |
| Erie | Pennsylvania | 16550 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Wilkes-Barre | Pennsylvania | 18711 | United States |
| Germantown | Tennessee | 38138 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75226 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030 | United States |
| Plano | Texas | 75093 | United States |
| The Woodlands | Texas | 77384 | United States |
| Burlington | Vermont | 05401 | United States |
| Falls Church | Virginia | 22042 | United States |
| Leesburg | Virginia | 20176 | United States |
| Spokane | Washington | 99204 | United States |
| Madison | Wisconsin | 53715 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Leuven | Belgium |
| Calgary | Alberta | Canada |
| London | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Calgary | Canada |
| Ottawa | Canada |
| La Rochelle | France |
| Nantes | France |
| Essen | Germany |
| Hanover | Germany |
| Ulm | Germany |
| Eindhoven | Netherlands |
| Maastricht | Netherlands |
| Nieuwegein | Netherlands |
| Rotterdam | Netherlands |
| Zurich | Switzerland |
| Liverpool | United Kingdom |
| Middlesbrough | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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