Rheos System for the Treatment of HFpEF Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT00957073
• Lead Sponsor: CVRx, Inc.

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2012-10
• Status Verified: 2021-04
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (22)

Cardiology Associates of Mobile, Inc.; 🇺🇸 Mobile, Alabama, United States

Apex Cardiology Consultants; 🇺🇸 Inglewood, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

St. Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

Florida Hospital Cardiovascular Institute/Florida Heart Group; 🇺🇸 Orlando, Florida, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

Heart and Vascular Institute of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Florida Cardiovascular Institute; 🇺🇸 Tampa, Florida, United States

The Care Group; 🇺🇸 Indianapolis, Indiana, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

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