Back to results

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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rheos® system

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Diastolic dysfunction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Cardiology Associates of Mobile, Inc.
Apex Cardiology Consultants
University of Southern California
St. Francis Hospital and Medical Center
Florida Hospital Cardiovascular Institute/Florida Heart Group
Orlando Regional Medical Center
Heart and Vascular Institute of Florida
Florida Cardiovascular Institute
The Care Group
Iowa Heart Center
Cardiovascular Institute of the South
Liberty Cardiovascular Specialists
Washington University
University of Rochester Medical Center
Forsyth Cardiovascular Research
Lindner Research Center
Ohio State University
Northwest Ohio Cardiology Consultants
Oklahoma Cardiovascular Research Group
Drexel University
Allegheny General Hospital
Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device

Medical Management

Arm Description

Rheos® system

Medical Management Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00957073

First Posted

August 10, 2009

Last Updated

April 7, 2021

Sponsor

CVRx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00957073

Brief Title

Rheos System for the Treatment of HFpEF Heart Failure

Acronym

HOPE4HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CVRx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, Diastolic dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Experimental

Arm Description

Rheos® system

Arm Title

Medical Management

Arm Type

No Intervention

Arm Description

Medical Management Therapy

Intervention Type

Device

Intervention Name(s)

Rheos® system

Other Intervention Name(s)

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

Intervention Description

Implant procedure

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Trial duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 1. Treating physician decision that the subject should not continue with therapy.

Overall Study Officials: