Rheos® Diastolic Heart Failure Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718939

Enrollment

Registered

2008-07-21

Start date

2008-07-31

Completion date

2012-07-31

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Heart Failure

Keywords

Diastolic Heart Failure, Cardiac dysfunction, Heart Failure

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.

Interventions

DEVICERheos 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026