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Rheos® Diastolic Heart Failure Trial

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ClinicalTrials.gov Identifier: NCT00718939
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Device: Rheos Baroreflex Activation Therapy System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Rheos® Diastolic Heart Failure Trial
Study Start Date : July 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Rheos ON
Study participants in this arm will have the device turn on for six months and remains on.
Device: 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.
Device: 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.



Primary Outcome Measures :
  1. Assess left ventricular mass index (LVMI). [ Time Frame: at six months post- randomization. ]
  2. Assess safety by evaluating all adverse events. [ Time Frame: through six months post -implant ]

Secondary Outcome Measures :
  1. To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. [ Time Frame: six months post-implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718939


Locations
Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, Germany, 61231
Krankenhaus Reinbek St.Adolfsstif
Hamburg-Reinbek, Germany, 21465
Medizinische Hoschschule Hannover
Hannover, Germany
University of Cologne
Koeln, Germany, 50924
Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Maximilian A Pichlmaier, MD Medizinische Hoschschule Hannover
Principal Investigator: Johannes Sperzel, MD Kerckhoff-Klinik Forschungsgesellschaft mbH
Principal Investigator: Prof. Uta Hoppe, MD University of Cologne
Principal Investigator: Herbert Naegele, MD Krankenhaus Reinbek St.Adolfsstif

Additional Information:
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00718939     History of Changes
Other Study ID Numbers: 360014
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by CVRx, Inc.:
Diastolic Heart Failure
Cardiac dysfunction
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases