Rheos® Diastolic Heart Failure Trial

Not Applicable

Completed

• Conditions: Diastolic Heart Failure
• Interventions: Device: Rheos Baroreflex Activation Therapy System

• Registration Number: NCT00718939
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rheos ON	Rheos Baroreflex Activation Therapy System	Study participants in this arm will have the device turn on for six months and remains on.
Rheos OFF	Rheos Baroreflex Activation Therapy System	Study participants in this arm will have the device turned off for 6 months and then turned on.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (4)

Krankenhaus Reinbek St.Adolfsstif; 🇩🇪 Hamburg-Reinbek, Germany

Medizinische Hoschschule Hannover; 🇩🇪 Hannover, Germany

University of Cologne; 🇩🇪 Koeln, Germany

Kerckhoff-Klinik Forschungsgesellschaft mbH; 🇩🇪 Bad Nauheim, Germany