Clinical trial NCT00957073: Rheos System for the Treatment of HFpEF Heart Failure
Official title: Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Diastolic dysfunction
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10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

Eligibility criteria: 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.

Primary outcomes:
measure: To ascertain long-term adverse events for subjects implanted with the device.
timeFrame: Trial duration
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Inglewood
country: United States
facility: Apex Cardiology Consultants
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Orlando
country: United States
facility: Florida Hospital Cardiovascular Institute/Florida Heart Group
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Heart and Vascular Institute of Florida
state: Florida
city: Tampa
country: United States
facility: Florida Cardiovascular Institute
state: Florida
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Liberty
country: United States
facility: Liberty Cardiovascular Specialists
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Cardiovascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Ohio State University
name: William Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Fred Weaver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michael Zile, MD
role: STUDY_CHAIR
affiliation: Inserm Centre d'Investigation, CHU de Nancy
name: Faiez Zannad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Heart and Vascular Institute
name: JoAnn Lindenfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.