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Company resources only allows adequate oversight for one pivotal trial at a time
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The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAROSTIM NEO System | Experimental | Subjects implanted with the BAROSTIM NEO System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAROSTIM NEO System and Medical Management | Device | Experimental: Device and Medical Management Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. | Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System. | For the duration of the study, up to ten years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Bakris, MD | The University of Chicago Medicine | Study Chair |
| John Bisognano, MD | University of Rochester | Study Chair |
| Fred Weaver, MD | Keck School of Medicine of the University of Southern California | Study Chair |
| William Abraham, MD | Ohio State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Rhythm Research Center | Phoenix | Arizona | 85006 | United States | ||
| University of Southern California |
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|
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| Los Angeles |
| California |
| 90033 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Cardiac and Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Michigan CardioVascular Institute | Saginaw | Michigan | 48601 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |