Status:
UNKNOWN
BAROSTIM NEO System in the Treatment of Heart Failure
Lead Sponsor:
CVRx, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
Detailed Description
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular eject...
Eligibility Criteria
Inclusion
- Actively participating in the Neo Randomized Heart Failure 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 :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01471860
Start Date
August 1 2011
End Date
August 11 2021
Last Update
November 4 2019
Active Locations (30)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
2
University of Alberta - Edmonton
Edmonton, Alberta, Canada, T6G 2B7
3
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
4
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6