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HOPE4HF: Rheos System for the Treatment of HFpEF Heart Failure

Sponsor
CVRx, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00957073
Collaborator
(none)
19
Enrollment
22
Locations
2
Arms
140
Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Rheos® system
 N/A

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. To ascertain long-term adverse events for subjects implanted with the device. [Trial duration]

      To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology Associates of Mobile, Inc. Mobile Alabama United States 36608
    2 Apex Cardiology Consultants Inglewood California United States 90301
    3 University of Southern California Los Angeles California United States 90033
    4 St. Francis Hospital and Medical Center Hartford Connecticut United States 06105
    5 Florida Hospital Cardiovascular Institute/Florida Heart Group Orlando Florida United States 32803
    6 Orlando Regional Medical Center Orlando Florida United States 32806
    7 Heart and Vascular Institute of Florida Saint Petersburg Florida United States 33709
    8 Florida Cardiovascular Institute Tampa Florida United States 33609
    9 The Care Group Indianapolis Indiana United States 46260
    10 Iowa Heart Center West Des Moines Iowa United States 50266
    11 Cardiovascular Institute of the South Houma Louisiana United States 70360
    12 Liberty Cardiovascular Specialists Liberty Missouri United States 64068
    13 Washington University Saint Louis Missouri United States 63110
    14 University of Rochester Medical Center Rochester New York United States 14642
    15 Forsyth Cardiovascular Research Winston-Salem North Carolina United States 27103
    16 Lindner Research Center Cincinnati Ohio United States 45219
    17 Ohio State University Columbus Ohio United States 43210
    18 Northwest Ohio Cardiology Consultants Toledo Ohio United States 43615
    19 Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma United States 73120
    20 Drexel University Philadelphia Pennsylvania United States 19102
    21 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    22 Medical University of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • CVRx, Inc.

    Investigators

    • Principal Investigator: William Abraham, MD, Ohio State University
    • Principal Investigator: Fred Weaver, MD, University of Southern California
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CVRx, Inc.
    ClinicalTrials.gov Identifier:
    NCT00957073
    Other Study ID Numbers:
    • 360017-001
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by CVRx, Inc.
    Heart Failure
    Diastolic dysfunction
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Apr 8, 2021