An interventional study of Rheos Baroreflex Activation Therapy System in Diastolic Heart Failure, sponsored by CVRx, Inc.. Completed at 4 sites in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by CVRx, Inc. · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →CVRx, Inc. is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants in this arm will have the device turn on for six months and remains on.
Device: Rheos Baroreflex Activation Therapy System
Study participants in this arm will have the device turned off for 6 months and then turned on.
Device: Rheos 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.
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
To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.
Time frame: six months post-implant
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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CVRx, Inc.