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The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.
The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Rheos® system |
|
| Medical Management | No Intervention | Medical Management Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rheos® system | Device | Implant procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To ascertain long-term adverse events for subjects implanted with the device. | To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device. | Trial duration |
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Inclusion Criteria:
Exclusion Criteria:
1. Treating physician decision that the subject should not continue with therapy.
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| Name | Affiliation | Role |
|---|---|---|
| William Abraham, MD | Ohio State University | Principal Investigator |
| Fred Weaver, MD | University of Southern California | Principal Investigator |
| Michael Zile, MD | Medical University of South Carolina | Study Chair |
| Faiez Zannad, MD | Inserm Centre d'Investigation, CHU de Nancy | Principal Investigator |
| JoAnn Lindenfield, MD | Vanderbilt Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Associates of Mobile, Inc. | Mobile | Alabama | 36608 | United States | ||
| Apex Cardiology Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21300307 | Derived | Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29. |
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| Inglewood |
| California |
| 90301 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| St. Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Florida Hospital Cardiovascular Institute/Florida Heart Group | Orlando | Florida | 32803 | United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| Heart and Vascular Institute of Florida | St. Petersburg | Florida | 33709 | United States |
| Florida Cardiovascular Institute | Tampa | Florida | 33609 | United States |
| The Care Group | Indianapolis | Indiana | 46260 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Liberty Cardiovascular Specialists | Liberty | Missouri | 64068 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Forsyth Cardiovascular Research | Winston-Salem | North Carolina | 27103 | United States |
| Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Northwest Ohio Cardiology Consultants | Toledo | Ohio | 43615 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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