An interventional study of Rheos® system in Heart Failure, sponsored by CVRx, Inc.. Completed at 22 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by CVRx, Inc. · Not applicable, Interventional, and Treatment
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.
The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 19 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:
Rheos® system
Device: Rheos® system
Medical Management Therapy
Implant procedure
Also known as: Rheos® Baroreflex Activation Therapy®, Neo Legacy® System, BAROSTIM NEO® LEGACY System
To ascertain long-term adverse events for subjects implanted with the device.
To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.
Time frame: Trial duration
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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CVRx, Inc.