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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00718939 |
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Date of registration:
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17/07/2008 |
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Primary sponsor: |
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Public title:
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Rheos® Diastolic Heart Failure Trial
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Scientific title:
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Rheos® Diastolic Heart Failure Trial |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00718939 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Netherlands
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Contacts
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Name:
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Johannes Sperzel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kerckhoff-Klinik Forschungsgesellschaft mbH |
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Name:
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Herbert Naegele, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Krankenhaus Reinbek St.Adolfsstif |
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Name:
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Maximilian A Pichlmaier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medizinische Hoschschule Hannover |
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Name:
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Prof. Uta Hoppe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cologne |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diastolic Heart Failure
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Intervention(s)
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Device: Rheos Baroreflex Activation Therapy System
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Primary Outcome(s)
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Assess left ventricular mass index (LVMI).
[Time Frame: at six months post- randomizatiom.]
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Assess safety by evaluating all adverse events.
[Time Frame: through six months post -implant]
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Secondary Outcome(s)
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To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.
[Time Frame: six months post-implant]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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