Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension

High Blood Pressure Clinical Trial

Official title:

Neo Non-Randomized Hypertension Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01471834
• Other study ID #: 360016
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Device:
• BAROSTIM NEO System

Drug:
• Medical Management

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta - Edmonton	Edmonton	Alberta
Canada	London-Lawson Health Research Institute	London	Ontario
Germany	University Hospital Cologne	Cologn
Germany	University Hospital Duesseldorf	Duesseldorf
Germany	Goettingen-Georg August University	Göttingen
Germany	Midizinische Hochschule Hannover	Hannover
Germany	Klinkum St. George Leipzig	Leipzig
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To access long-term adverse events in participants implanted with the BAROSTIM NEO System.	Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with CVRx's BAROSTIM NEO System.	For the duration of the study, up to 10 years.