Rheos® Diastolic Heart Failure Trial

CVRx

Status: Completed

Conditions: Diastolic Heart Failure

Treatments: Device: Rheos Baroreflex Activation Therapy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718939

360014

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Rheos ON

Other group

Description:

Study participants in this arm will have the device turn on for six months and remains on.

Treatment:

Device: Rheos Baroreflex Activation Therapy System

Rheos OFF

Other group

Description:

Study participants in this arm will have the device turned off for 6 months and then turned on.

Treatment:

Device: Rheos Baroreflex Activation Therapy System