BAROSTIM NEO Hypertension 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 |
Recruitment Status :
Suspended
(Company resources only allows adequate oversight for one pivotal trial at a time)
First Posted : September 5, 2012
Last Update Posted : December 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uncontrolled Hypertension | Device: BAROSTIM NEO System and Medical Management | Not Applicable |
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:
- Office Cuff Blood Pressure
- Physical Assessment
- Subject Medications
- Serious adverse events
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | BAROSTIM NEO Hypertension Pivotal Trial |
Study Start Date : | April 12, 2013 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | March 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
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Device: BAROSTIM NEO System and Medical Management
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. Other Name: Neo System |
- To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. [ Time Frame: For the duration of the study, up to ten years. ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
- Have signed a revised approved informed consent form for continued participation in this study.
Exclusion Criteria:
- Treating physician decision that the subject should not continue with therapy.

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
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 |
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 |
Other Study ID Numbers: |
360039 |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | December 1, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Hypertension Vascular Diseases Cardiovascular Diseases |