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The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device and Medical Management | Experimental | Medical Management, to be determined by the participant's physician, described as:
Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAROSTIM NEO System | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System | Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System. | For the duration of the study, up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uta Hoppe, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
| University of Alberta - Edmonton |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25982108 | Result | Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14. | |
| 29705650 |
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| Medical Management |
| Drug |
|
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| University of British Columbia | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| CHRU de Lille | Lille | 590347 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CHU de Toulouse | Toulouse | 31073 | France |
| Vivantes Hospital Berlin | Berlin | 10967 | Germany |
| Immanuel Hospital Bernau-Heart Center Brandenburg | Bernau | 16321 | Germany |
| University Hospital Cologne | Cologne | 50937 | Germany |
| University Hospital Essen | Essen | 45122 | Germany |
| CVC Frankfurt | Frankfurt | 60389 | Germany |
| University Hospital Giessen | Giessen | 35392 | Germany |
| Georg August University - Goettingen | Göttingen | 37075 | Germany |
| Klinik St. Georg, Hamburg | Hamburg | 20099 | Germany |
| University Heart Center Hamburg | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| University Hospital of Schleswig-Holstein, Kiel Campus | Kiel | 24105 | Germany |
| Klinikum St. Georg Leipzig | Leipzig | 04129 | Germany |
| Klinikum Ludenscheid | Lüdenscheid | 58515 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| Lukas Hospital Neuss | Neuss | 41464 | Germany |
| Oldenburg Hospital | Oldenburg | 26133 | Germany |
| Reinbek Hospital, St. Adolf-Stift | Reinbek | 21465 | Germany |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliero Universitaria Opedali | Ancona | 60126 | Italy |
| Azienda Ospedaliera Spedali Riuniti Di Bergamo | Bergamo | 24128 | Italy |
| Azienda Ospedaliero - Universitaria Careggi | Florence | 50134 | Italy |
| Istituto Scientifico San Luca | Milan | 20149 | Italy |
| Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21. |
| 26011593 | Derived | Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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