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Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring 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 Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.
Model 4195 LV lead complication-free survivability will be summarized.
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| Measure | Description | Time Frame |
|---|---|---|
| Lead-related complication rate. | Implant to 5 years post-implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Types of Model 4195 lead-related events | 5 years post implant |
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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 a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| 4195 LV Lead Chronic Performance Study Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | United States | ||||
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| Phoenix |
| Arizona |
| United States |
| Scottsdale | Arizona | United States |
| Chula Vista | California | United States |
| Redding | California | United States |
| Salinas | California | United States |
| Stanford | California | United States |
| Torrance | California | United States |
| Colorado Springs | Colorado | United States |
| New Haven | Connecticut | United States |
| Bradenton | Florida | United States |
| Clearwater | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Albany | Georgia | United States |
| Marietta | Georgia | United States |
| Indianapolis | Indiana | United States |
| Newburgh | Indiana | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Edgewood | Kentucky | United States |
| Louisville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Covington | Louisiana | United States |
| Salisbury | Maryland | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Grand Blanc | Michigan | United States |
| Marquette | Michigan | United States |
| Robbinsdale | Minnesota | United States |
| Rochester | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| Henderson | Nevada | United States |
| West Orange | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| Lancaster | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| Burlington | Vermont | United States |
| Falls Church | Virginia | United States |
| Olympia | Washington | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Calgary | Alberta | Canada |
| Kingston | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Québec | Quebec | Canada |
| Middlesbrough | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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