Rheos System for the Treatment of HFpEF Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00957073

Run by

CVRx, Inc.

People needed

19

Starts

2009-08-01

Expected to finish

2021-04-01

Last updated by the study team

2021-04-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001).
• Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.

You may not qualify if…

• Treating physician decision that the subject should not continue with therapy.

Where it is running

• Cardiology Associates of Mobile, Inc. — Mobile, Alabama, United States
• Apex Cardiology Consultants — Inglewood, California, United States
• University of Southern California — Los Angeles, California, United States
• St. Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Florida Hospital Cardiovascular Institute/Florida Heart Group — Orlando, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• Heart and Vascular Institute of Florida — St. Petersburg, Florida, United States
• Florida Cardiovascular Institute — Tampa, Florida, United States
• The Care Group — Indianapolis, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Liberty Cardiovascular Specialists — Liberty, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Forsyth Cardiovascular Research — Winston-Salem, North Carolina, United States
• Lindner Research Center — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Northwest Ohio Cardiology Consultants — Toledo, Ohio, United States
• Oklahoma Cardiovascular Research Group — Oklahoma City, Oklahoma, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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