Rheos System for the Treatment of HFpEF Heart Failure

NCT ID: NCT00957073

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device

Rheos® system

Group Type EXPERIMENTAL

Rheos® system

Intervention Type DEVICE

Implant procedure

Medical Management

Medical Management Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rheos® system

Implant procedure

Intervention Type DEVICE

Other Intervention Names

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Rheos® Baroreflex Activation Therapy® Neo Legacy® System BAROSTIM NEO® LEGACY System

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CVRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Fred Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Michael Zile, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Faiez Zannad, MD

Role: PRINCIPAL_INVESTIGATOR

Inserm Centre d'Investigation, CHU de Nancy

JoAnn Lindenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Heart and Vascular Institute

Locations

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Cardiology Associates of Mobile, Inc.

Mobile, Alabama, United States

Site Status

Apex Cardiology Consultants

Inglewood, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Florida Hospital Cardiovascular Institute/Florida Heart Group

Orlando, Florida, United States

Site Status

Orlando Regional Medical Center

Orlando, Florida, United States

Site Status

Heart and Vascular Institute of Florida

St. Petersburg, Florida, United States

Site Status

Florida Cardiovascular Institute

Tampa, Florida, United States

Site Status

The Care Group

Indianapolis, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Cardiovascular Institute of the South

Houma, Louisiana, United States

Site Status

Liberty Cardiovascular Specialists

Liberty, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Forsyth Cardiovascular Research

Winston-Salem, North Carolina, United States

Site Status

Lindner Research Center

Cincinnati, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Northwest Ohio Cardiology Consultants

Toledo, Ohio, United States

Site Status

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.

Reference Type DERIVED
PMID: 21300307 (View on PubMed)

Other Identifiers

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360017-001

Identifier Type: -

Identifier Source: org_study_id

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