Rheos® Diastolic Heart Failure Trial
Not Applicable
Completed
- Conditions
- Diastolic Heart Failure
- Registration Number
- NCT00718939
- Lead Sponsor
- CVRx, Inc.
- 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 one year post implant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess left ventricular mass index (LVMI). at six months post- randomization. Assess safety by evaluating all adverse events. through six months post -implant
- Secondary Outcome Measures
Name Time Method To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. six months post-implant
Trial Locations
- Locations (4)
Kerckhoff-Klinik Forschungsgesellschaft mbH
🇩🇪Bad Nauheim, Germany
Krankenhaus Reinbek St.Adolfsstif
🇩🇪Hamburg-Reinbek, Germany
Medizinische Hoschschule Hannover
🇩🇪Hannover, Germany
University of Cologne
🇩🇪Koeln, Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH🇩🇪Bad Nauheim, Germany