Rheos System for the Treatment of HFpEF Heart Failure (HOPE4HF)

April 7, 2021 updated by: CVRx, Inc.

Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Cardiology Associates of Mobile, Inc.
    • California
      • Inglewood, California, United States, 90301
        • Apex Cardiology Consultants
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • St. Francis Hospital and Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Cardiovascular Institute/Florida Heart Group
      • Saint Petersburg, Florida, United States, 33709
        • Heart and Vascular Institute of Florida
      • Tampa, Florida, United States, 33609
        • Florida Cardiovascular Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Care Group
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Missouri
      • Liberty, Missouri, United States, 64068
        • Liberty Cardiovascular Specialists
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Cardiovascular Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Lindner Research Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology Consultants
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device
Rheos® system
Device: Rheos® system
Implant procedure
Other Names:
  • Rheos® Baroreflex Activation Therapy®
  • Neo Legacy® System
  • BAROSTIM NEO® LEGACY System
No Intervention: Medical Management
Medical Management Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To ascertain long-term adverse events for subjects implanted with the device.
Time Frame: Trial duration
To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.
Trial duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Study Chair: Michael Zile, MD, Medical University of South Carolina
  • Principal Investigator: Faiez Zannad, MD, Inserm Centre d'Investigation, CHU de Nancy
  • Principal Investigator: JoAnn Lindenfield, MD, Vanderbilt Heart and Vascular Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360017-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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