Rheos System for the Treatment of HFpEF Heart Failure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00957073

Acronym

HOPE4HF

Enrollment

Registered

2009-08-12

Start date

2009-08-31

Completion date

2021-04-01

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Diastolic dysfunction

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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

Interventions

DEVICERheos® system

Implant procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026