Status:
UNKNOWN
Effect Baroreflex Activation Therapy on the Carotid Body
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
CVRx, Inc.
Conditions:
Hypertension Resistant To Conventional Therapy
Baroreflex
Eligibility:
All Genders
21-75 years
Brief Summary
Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in blood pressure in patients with resistant hypertension. Since the activation electrodes are implanted at t...
Eligibility Criteria
Inclusion
- Be currently implanted with Rheos system and have completed the 13-month follow-up period.
- Be on stable anti-hypertensive therapy for at least 4 weeks prior to inclusion, where stable is defined as no changes in medications or dosage of medications.
- Have at least one functional carotid baroreflex activation electrode.
- Have signed and approved informed consent form for participation in this study.
Exclusion
- Myocardial infarction (MI) or cerebral vascular accident (CVA) within the past 90 days, or subject is still unstable from a prior MI or CVA that occurred more than 90 days ago.
- Are unable or unwilling to comply with the protocol requirements of this study.
- Diagnosed with severe chronic obstructive lung disease (COPD/asthma GOLD stadium III and IV).
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02210923
Start Date
October 1 2013
Last Update
August 7 2014
Active Locations (1)
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1
Maastricht University Medical Center+
Maastricht, Netherlands, 6229 HX