NCT00957073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3.2 years

First QC Date

August 10, 2009

Last Update Submit

April 7, 2021

Conditions

Heart Failure

Keywords

Heart FailureDiastolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • To ascertain long-term adverse events for subjects implanted with the device.

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

    Trial duration

Study Arms (2)

Device

EXPERIMENTAL

Rheos® system

Device: Rheos® system

Medical Management

NO INTERVENTION

Medical Management Therapy

Interventions

Rheos® systemDEVICE

Implant procedure

Also known as: Rheos® Baroreflex Activation Therapy®, Neo Legacy® System, BAROSTIM NEO® LEGACY System
Device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, 36608, United States

Location

Apex Cardiology Consultants

Inglewood, California, 90301, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Florida Hospital Cardiovascular Institute/Florida Heart Group

Orlando, Florida, 32803, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33709, United States

Location

Florida Cardiovascular Institute

Tampa, Florida, 33609, United States

Location

The Care Group

Indianapolis, Indiana, 46260, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Liberty Cardiovascular Specialists

Liberty, Missouri, 64068, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Forsyth Cardiovascular Research

Winston-Salem, North Carolina, 27103, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 21300307DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • William Abraham, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Fred Weaver, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Michael Zile, MD

    Medical University of South Carolina

    STUDY CHAIR

  • Faiez Zannad, MD

    Inserm Centre d'Investigation, CHU de Nancy

    PRINCIPAL INVESTIGATOR

  • JoAnn Lindenfield, MD

    Vanderbilt Heart and Vascular Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2012

Study Completion

April 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

US(22)