Status:
COMPLETED
Device Based Therapy in Hypertension Extension Trial
Lead Sponsor:
CVRx, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond...
Detailed Description
This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under ...
Eligibility Criteria
Inclusion
- Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001)
- Have signed an approved informed consent form for participation in this study
Exclusion
- Are unable to comply with protocol requirements.
- Are enrolled in another concurrent clinical trial.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00710294
Start Date
August 1 2005
End Date
October 1 2011
Last Update
October 31 2011
Active Locations (5)
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1
University Hospital Bad Oeynhausen
Bad Oeynhausen, Germany
2
Charité Campus Buch
Berlin, Germany
3
University Hospital Hannover
Hanover, Germany
4
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands