Rheos® Diastolic Heart Failure Trial

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.

Study Overview

• Status: Completed
• Conditions: Diastolic Heart Failure
• Intervention / Treatment: Device: Rheos Baroreflex Activation Therapy System

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik Forschungsgesellschaft mbH
  • Hamburg-Reinbek, Germany, 21465
    • Krankenhaus Reinbek St.Adolfsstif
  • Hannover, Germany
    • Medizinische Hoschschule Hannover
  • Koeln, Germany, 50924
    • University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.	six months post-implant

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 17, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Heart Failure; Diastolic Heart Failure; Cardiac dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: 360014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No