BAROSTIM NEO HTN Pivotal Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01679132 |
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Recruitment Status :
Suspended
(Study was suspended as company resources will only allow adequate oversight for one pivotal trial at a time.)
First Posted : September 5, 2012
Last Update Posted : February 28, 2018
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Sponsor:
CVRx, Inc.
Information provided by (Responsible Party):
CVRx, Inc.
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Brief Summary:
The BAROSTIM NEO HTN trial is a prospective, randomized, controlled trial to demonstrate the safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.
Currently, the BAROSTIM NEO HTN trial is not actively enrolling. CVRx is conducting long-term follow-up of patients implanted with the BAROSTIM NEO device. This update was not done for any subject protection concerns that would preclude continuation of the investigation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uncontrolled Hypertension | Device: Neo Baroreflex Activation Therapy System Other: Standard of care medical management only | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 310 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Open Label |
| Primary Purpose: | Treatment |
| Official Title: | CVRx BAROSTIM NEO Hypertension Pivotal Trial |
| Study Start Date : | January 2013 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | September 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Neo Baroreflex Activation Therapy System
Patients are randomized to receive Neo Baroreflex Activation Therapy System device plus optimal medical management.
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Device: Neo Baroreflex Activation Therapy System
Other Names:
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Active Comparator: Medical Management Arm
Patients are randomized to receive optimal medical management alone.
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Other: Standard of care medical management only
Patients will continue with medical therapy for standard of care of their hypertension. |
Primary Outcome Measures :
- Primary Safety Objective [ Time Frame: 30 days ]To demonstrate the safety of the Neo system by reporting all adverse events that are complications between implant and 30 days post-implant in the device arm. The incidence of adverse events will be categorized by relatedness.
- Primary Efficacy Objective [ Time Frame: 6 months ]To demonstrate a significant reduction between the two treatment arms of protocol defined automated office cuff systolic blood pressure (SBP) from baseline to 6 months post-activation.
Secondary Outcome Measures :
- Secondary Efficacy Objective 1 [ Time Frame: 12 months ]To demonstrate a significant reduction within the device arm of office cuff systolic blood pressure (SBP) between baseline and 12 months post-activation.
- Secondary Efficacy Objective 2 [ Time Frame: 12 months ]To demonstrate a significant reduction within the device arm of 24-hour ambulatory systolic blood pressure (SBP) between baseline and 12 months post-activation.
- Secondary Safety Objective [ Time Frame: 6 months ]To demonstrate the safety of the Neo system by reporting all hypertensive emergencies from activation to 6 months post activation. The incidence of hypertensive emergencies will be categorized by study arm.
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria Highlights:
- Age at least 21 years and no more than 80 years at the time of randomization.
- On four or more maximally tolerated anti-hypertensive medications, one of which is a diuretic. The antihypertensive medication regimen must remain unchanged for 4 weeks prior to screening and must be expected to remain unchanged for at least 6 months during follow-up.
- Protocol defined systolic blood pressure greater than or equal to 160 mmHg.
- Protocol defined 24-hour Ambulatory Blood Pressure Monitoring (ABPM) greater than or equal to 135 mmHg.
- Serum estimated glomerular filtration rate (eGFR) > 29 mL/min/1.73 m^2.
- Appropriate surgical candidate.
- Women of childbearing potential must use a medically accepted method of birth control and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization.
Exclusion Criteria Highlights:
- Known or suspected baroreflex failure or autonomic neuropathy.
- Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months.
- Hypertension secondary to an identifiable and treatable cause other than sleep apnea.
- Prior surgery, radiation, or endovascular stent placement in the carotid sinus region.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679132
Locations
| United States, Arizona | |
| Arizona Heart Rhythm Research Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Florida Hospital | |
| Orlando, Florida, United States, 32803 | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Louisiana | |
| Cardiovascular Institute of the South | |
| Houma, Louisiana, United States, 70360 | |
| United States, Michigan | |
| Cardiac and Vascular Research Center of Northern Michigan | |
| Petoskey, Michigan, United States, 49770 | |
| Michigan CardioVascular Institute | |
| Saginaw, Michigan, United States, 48601 | |
| United States, Nevada | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Wisconsin | |
| Aspirus Wausau Hospital | |
| Wausau, Wisconsin, United States, 54401 | |
Sponsors and Collaborators
CVRx, Inc.
Investigators
| Study Chair: | 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 |
| Responsible Party: | CVRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01679132 History of Changes |
| Other Study ID Numbers: |
360039 |
| First Posted: | September 5, 2012 Key Record Dates |
| Last Update Posted: | February 28, 2018 |
| Last Verified: | February 2018 |
Keywords provided by CVRx, Inc.:
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Hypertension High Blood Pressure Blood Pressure Cardiovascular Disease Resistant Hypertension |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases |