Status:
COMPLETED
Rheos® Diastolic Heart Failure Trial
Lead Sponsor:
CVRx, Inc.
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to on...
Eligibility Criteria
Inclusion
- Be at least 21 years of age.
- Have bilateral carotid bifurcations that are below the level of the mandible.
- Have a left ventricular ejection fraction ≥ 45%.
- Clinical Heart Failure with elevated BNP or NT-Pro-BNP.
Exclusion
- History of or suspected baroreflex failure or autonomic neuropathy.
- History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
- Organ or hematologic transplant.
- History of prior surgery, radiation, or stent placement in carotid sinus region.
- History of severe chronic kidney disease.
- Life expectancy to less than one year.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00718939
Start Date
July 1 2008
End Date
July 1 2012
Last Update
October 21 2016
Active Locations (4)
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1
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, Germany, 61231
2
University of Cologne
Cologne, Germany, 50924
3
Krankenhaus Reinbek St.Adolfsstif
Hamburg-Reinbek, Germany, 21465
4
Medizinische Hoschschule Hannover
Hanover, Germany