BAROSTIM NEO Hypertension Pivotal Trial
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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 : October 30, 2020
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | August 31, 2012 | ||||||||||||
First Posted Date ICMJE | September 5, 2012 | ||||||||||||
Last Update Posted Date | October 30, 2020 | ||||||||||||
Study Start Date ICMJE | April 12, 2013 | ||||||||||||
Estimated Primary Completion Date | March 2026 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | BAROSTIM NEO Hypertension Pivotal Trial | ||||||||||||
Official Title ICMJE | BAROSTIM NEO Hypertension Pivotal Trial | ||||||||||||
Brief Summary | 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). | ||||||||||||
Detailed Description | 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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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Uncontrolled Hypertension | ||||||||||||
Intervention ICMJE | 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
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Study Arms ICMJE | Experimental: BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
Intervention: Device: BAROSTIM NEO System and Medical Management
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Suspended | ||||||||||||
Actual Enrollment ICMJE |
10 | ||||||||||||
Original Estimated Enrollment ICMJE |
600 | ||||||||||||
Estimated Study Completion Date ICMJE | March 2026 | ||||||||||||
Estimated Primary Completion Date | March 2026 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 80 Years (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01679132 | ||||||||||||
Other Study ID Numbers ICMJE | 360039 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Responsible Party | CVRx, Inc. | ||||||||||||
Study Sponsor ICMJE | CVRx, Inc. | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | CVRx, Inc. | ||||||||||||
Verification Date | October 2020 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |