Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2008-07-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rheos ON
Study participants in this arm will have the device turn on for six months and remains on.
Rheos Baroreflex Activation Therapy System
The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.
Rheos OFF
Study participants in this arm will have the device turned off for 6 months and then turned on.
Rheos Baroreflex Activation Therapy System
The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.
Interventions
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Rheos Baroreflex Activation Therapy System
The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maximilian A Pichlmaier, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Hoschschule Hannover
Johannes Sperzel, MD
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff-Klinik Forschungsgesellschaft mbH
Prof. Uta Hoppe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Herbert Naegele, MD
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Reinbek St.Adolfsstif
Locations
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Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, , Germany
University of Cologne
Cologne, , Germany
Krankenhaus Reinbek St.Adolfsstif
Hamburg-Reinbek, , Germany
Medizinische Hoschschule Hannover
Hanover, , Germany
Countries
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Related Links
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Related Info
Other Identifiers
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360014
Identifier Type: -
Identifier Source: org_study_id
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