Status:
ACTIVE_NOT_RECRUITING
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension
Lead Sponsor:
CVRx, Inc.
Conditions:
High Blood Pressure
Eligibility:
All Genders
21-80 years
Phase:
NA
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 hyper...
Eligibility Criteria
Inclusion
- Actively participating in the Neo Non-Randomized Hypertension Study.
- Have signed a revised approved informed consent form for continued participation in this study.
Exclusion
- Treating physician decision that the subject should not continue with therapy.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01471834
Start Date
June 1 2011
End Date
August 1 2026
Last Update
July 15 2025
Active Locations (9)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta - Edmonton
Edmonton, Alberta, Canada, T2P 1C4
3
London-Lawson Health Research Institute
London, Ontario, Canada, N6G 2V2
4
University Hospital Cologne
Cologn, Germany, 50924