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.

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Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff-Klinik Forschungsgesellschaft mbH, Bad Nauheim, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rheos Baroreflex Activation Therapy System

Device

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.

Primary outcomes

Assess left ventricular mass index (LVMI).

Time frame: at six months post- randomization.
Assess safety by evaluating all adverse events.

Time frame: through six months post -implant

Secondary outcomes

To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.

Time frame: six months post-implant

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jul 21, 2008
Registry last updated: Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed