Clinical trial NCT01679132: BAROSTIM NEO Hypertension Pivotal Trial
Official title: BAROSTIM NEO Hypertension Pivotal Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Uncontrolled Hypertension
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
timeFrame: For the duration of the study, up to ten years.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Research Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Saginaw
country: United States
facility: Michigan CardioVascular Institute
state: Michigan
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
Study officials:
affiliation: The University of Chicago Medicine
name: George Bakris, MD
role: STUDY_CHAIR
affiliation: University of Rochester
name: John Bisognano, MD
role: STUDY_CHAIR
affiliation: Keck School of Medicine of the University of Southern California
name: Fred Weaver, MD
role: STUDY_CHAIR
affiliation: Ohio State University
name: William Abraham, MD
role: STUDY_CHAIR
References: