Clinical trial NCT01471834: Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension
Official title: Neo Non-Randomized Hypertension Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 40
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: To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

Detailed description: The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.

Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.

All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

* Physical Assessment
* Office Cuff Blood Pressure
* Subject Medications
* Serious adverse events

Eligibility criteria: Inclusion Criteria:

* Actively participating in the Neo Non-Randomized Hypertension Study.
* 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 access long-term adverse events in participants implanted with the BAROSTIM NEO System.
timeFrame: For the duration of the study, up to 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Edmonton
state: Alberta
city: London
country: Canada
facility: London-Lawson Health Research Institute
state: Ontario
city: Cologn
country: Germany
facility: University Hospital Cologne
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
city: Göttingen
country: Germany
facility: Goettingen-Georg August University
city: Hannover
country: Germany
facility: Midizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Klinkum St. George Leipzig
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Hannover Medical School
name: Hermann Haller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.