Rheos® Diastolic Heart Failure Trial

Study Overview
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Brief Summary
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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.

Official Title
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Rheos® Diastolic Heart Failure Trial

Conditions
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Diastolic Heart Failure

Intervention / Treatment
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* Device: Rheos Baroreflex Activation Therapy System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rheos ON<br>Study participants in this arm will have the device turn on for six months and remains on. | Device: Rheos Baroreflex Activation Therapy System<br>* 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.<br>|
| Other: Rheos OFF<br>Study participants in this arm will have the device turned off for 6 months and then turned on. | Device: Rheos Baroreflex Activation Therapy System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diastolic Heart Failure, Cardiac dysfunction, Heart Failure