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The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival from Heart Failure Hospitalization and All-Cause Mortality | To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. | 3 years |
| Survival from Heart Failure Event and All-Cause Mortality | To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Heart failure patients that are implanted with a Medtronic CRT-D device and meet the expanded indication criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Anchorage |
| Alaska |
| 99508 |
| United States |
| Chandler | Arizona | 85226 | United States |
| Gilbert | Arizona | 85295 | United States |
| Jonesboro | Arkansas | 72410 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Bakersfield | California | 93301 | United States |
| Chula Vista | California | 91910 | United States |
| Los Angeles | California | 90048 | 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 |
| Atlanta | Georgia | 30308 | 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 |
| Coon Rapids | Minnesota | 55433 | United States |
| Minneapolis | Minnesota | 55407 | United States |
| Robbinsdale | Minnesota | 55422 | United States |
| Rochester | Minnesota | 55905 | United States |
| Saint Cloud | Minnesota | 56303 | United States |
| Saint Paul | Minnesota | 55102 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Columbia | Missouri | 65201 | United States |
| Kansas City | Missouri | 64111 | United States |
| Lebanon | New Hampshire | 03766 | United States |
| Morristown | New Jersey | 07960 | United States |
| Ocean City | New Jersey | 07712 | United States |
| Ridgewood | New Jersey | 07450 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Bay Shore | New York | 11706 | United States |
| Huntington | New York | 11743 | United States |
| Manhasset | New York | 11030 | United States |
| New Hyde Park | New York | 11040 | United States |
| New York | New York | 10075 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Staten Island | New York | 10305 | United States |
| The Bronx | New York | 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 |
| Columbus | Ohio | 43210 | United States |
| Toledo | Ohio | 43608 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Portland | Oregon | 97220 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| Bethlehem | Pennsylvania | 18017 | United States |
| Danville | Pennsylvania | 17822 | United States |
| Erie | Pennsylvania | 16550 | United States |
| Lancaster | Pennsylvania | 17604 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Wilkes-Barre | Pennsylvania | 18711 | United States |
| Wynnewood | Pennsylvania | 19096 | United States |
| Columbia | South Carolina | 29204 | United States |
| Germantown | Tennessee | 38138 | United States |
| Nashville | Tennessee | 37212 | 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 |
| San Antonio | Texas | 78229 | United States |
| The Woodlands | Texas | 77384 | United States |
| Burlington | Vermont | 05401 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Falls Church | Virginia | 22042 | United States |
| Leesburg | Virginia | 20176 | United States |
| Olympia | Washington | 98506 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98402 | United States |
| Madison | Wisconsin | 53715 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Leuven | Belgium |
| Calgary | Alberta | T2N 4N1 | Canada |
| London | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| La Rochelle | France |
| Nantes | France |
| Essen | Germany |
| Hanover | Germany |
| Homburg | Germany |
| Ulm | Germany |
| Reggio Emilia | Italy |
| Eindhoven | Netherlands |
| Maastricht | Netherlands |
| Nieuwegein | Netherlands |
| Rotterdam | Netherlands |
| Skövde | Sweden |
| 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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