Clinical trial NCT01720160: BAROSTIM® Hope for Heart Failure Study
Official title: Barostim HOPE4HF Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Systolic Heart Failure
Congestive Heart Failure
Reduced left ventricular ejection fraction
HFrEF
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 98
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 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).

Detailed description: A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.

Eligibility criteria: Inclusion Criteria:

* Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
* Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

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

Primary outcomes:
measure: Heart failure metric improvements from baseline
timeFrame: 12 months
measure: System and procedure related adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Research Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Atlantis
country: United States
facility: ACRC - Cardiology
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Naperville
country: United States
facility: Advocate Medical Group
state: Illinois
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Brighton
country: United States
facility: St Elizabeth's Medical Center
state: Massachusetts
city: Midland
country: United States
facility: Mid-Michigan Medical Center Midland
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Amarillo
country: United States
facility: Lonestar Heart Center
state: Texas
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Heart & Vascular Institute
state: Wisconsin
Study officials:
affiliation: Medical University of South Carolina
name: Michael Zile, MD
role: STUDY_CHAIR
affiliation: Ohio State University
name: William Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Fred Weaver, MD
role: PRINCIPAL_INVESTIGATOR
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: Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
citation: Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
citation: Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.