Download Barostim neo HOPE4HF Trial

Barostim neo™ HOPE4HF™ Trial
Study Overview
The Barostim neo HOPE4HF study is a prospective, randomized, controlled trial. It is being conducted by
heart failure physician specialists and vascular surgeons at up to 20 clinical sites in the United States. The
overall purpose of the study is to determine if Barostim neo is safe and effective for people that are not
being effectively treated with their heart failure treatments.
Approximately 60 patients will participate in the study. Patients will be randomized in a 1:1 ratio to
receive Barostim neo and optimal medical management or to receive medical management alone. The
study follow-up period will be two years, with multiple follow-up visits required.
Study Design
Initial Study Qualifications
A person will be considered for study participation if they meet the following initial qualifications:
 Age 21 or above
 Left ventricular ejection fraction of ≤ 35%
 Symptomatic AHA/ACC Stage C Heart Failure and NYHA Class III
 Resting heart rate between 60 bpm and 100 bpm (beats per minute)
 Systolic blood pressure (SBP) ≥ 100 mmHg
For more information on the study, go to GET Study URL or GET call 888 Number.
CVRx Contacts:
John Brintnall
Chief Financial Officer
[email protected]
Phone: 763.416.2853
Mary McGrory-Usset
Corporate Communications
[email protected]
Phone: 651.308.8225
CVRx, Inc.
9201 West Broadway Avenue
Suite 650
Minneapolis, MN 55445
www.cvrx.com
Caution: In the United States, Barostim neo is an investigational device and is limited by Federal (or
United States) law to investigational use only.
CVRx, Barostim neo, and HOPE4HF are trademarks of CVRx, Inc. registered in the United States
Trademark Office.
© CVRx, Inc. 2012. All rights reserved.
950180-001 Rev. A