Uncontrolled Hypertension
Conditions
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: * Office Cuff Blood Pressure * Physical Assessment * Subject Medications * Serious adverse events
Interventions
DEVICEBAROSTIM 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.
Sponsors
CVRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. | 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. |
Countries
United States
Contacts
STUDY_CHAIRGeorge Bakris, MD
The University of Chicago Medicine
STUDY_CHAIRJohn Bisognano, MD
University of Rochester
STUDY_CHAIRFred Weaver, MD
Keck School of Medicine of the University of Southern California
STUDY_CHAIRWilliam Abraham, MD
Ohio State University
Outcome results
None listed