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Rheos System for the Treatment of HFpEF Heart Failure

NCT00957073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Rheos® system

Implant procedure

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • William Abraham, MD · Ohio State University

  • Fred Weaver, MD · University of Southern California

  • Michael Zile, MD · Medical University of South Carolina

  • Faiez Zannad, MD · Inserm Centre d'Investigation, CHU de Nancy

  • JoAnn Lindenfield, MD · Vanderbilt Heart and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-10-31
Completion
2021-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957073 on ClinicalTrials.gov