Rheos® Diastolic Heart Failure Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00718939
First received: July 17, 2008
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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 Intervention
Diastolic Heart Failure
Device: Rheos Baroreflex Activation Therapy System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Rheos® Diastolic Heart Failure Trial

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Assess left ventricular mass index (LVMI). [ Time Frame: at six months post- randomizatiom. ] [ Designated as safety issue: No ]
  • Assess safety by evaluating all adverse events. [ Time Frame: through six months post -implant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. [ Time Frame: six months post-implant ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00718939     History of Changes
Other Study ID Numbers: 360014
Study First Received: July 17, 2008
Last Updated: May 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on September 30, 2014