Status:
COMPLETED
Device Based Therapy in Hypertension Trial
Lead Sponsor:
CVRx, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.
Detailed Description
The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients ...
Eligibility Criteria
Inclusion
- Be at least 21 years of age.
- Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
- Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- Must be certified by the investigator as compliant to taking full doses of medications.
- Have signed an approved informed consent form for participation in this study.
Exclusion
- Have been diagnosed with:
- Baroreflex failure or significant orthostatic hypotension
- Cardiac brady arrhythmias or chronic atrial fibrillation
- Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
- Have prior surgery or radiation in either carotid sinus region
- Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
- Are pregnant or contemplating pregnancy during the 4-month follow-up period.
- Are on dialysis
- Have hypertension secondary to a treatable cause
- Have clinically significant cardiac valvular disease
- Are unable to comply with protocol requirements.
- Are unlikely to survive the protocol follow-up period
- Are enrolled in another concurrent clinical trial
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00710190
Start Date
July 1 2003
End Date
October 1 2011
Last Update
October 21 2016
Active Locations (9)
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1
University Hospital Hradec Kralove
Hradec Králové, Czechia
2
University Hospital Bad Oeynhausen
Bad Oeynhausen, Germany
3
Charité Campus Buch
Berlin, Germany
4
Uniklinik Essen
Essen, Germany