BAROSTIM® Hope for Heart Failure Study

NCT01720160 | Unknown DMC FDA Device

• 1 other identifier: 360032-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 23

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).

Conditions

Heart Failure

Keywords

Systolic Heart Failure; Congestive Heart Failure; Reduced left ventricular ejection fraction; HFrEF

Outcome Measures

Primary Outcomes (2)

• Heart failure metric improvements from baseline

  To describe changes in measures compared to baseline.

  12 months

• System and procedure related adverse events

  To demonstrate the safety of the Neo system in a heart failure population.

  6 months

Study Arms (2)

Device

EXPERIMENTAL

1\) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.

Device: BAROSTIM NEO® System; Other: Standard of care medical managment therapy for heart failure

Medical Management

ACTIVE COMPARATOR

Standard of care medical management therapy for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.

Other: Standard of care medical managment therapy for heart failure

Interventions

BAROSTIM NEO® System DEVICE

Implant procedure

Also known as: Neo® System

Device

Standard of care medical managment therapy for heart failure OTHER

Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.

Device; Medical Management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (23)

Southwest Cardiovascular Associates

Mesa, Arizona, 85206, United States

Location

Arizona Heart Rhythm Research Center

Phoenix, Arizona, 53226, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

ACRC - Cardiology

Atlantis, Florida, 33462, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Advocate Medical Group

Naperville, Illinois, 60540, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

St Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Mid-Michigan Medical Center Midland

Midland, Michigan, 48670, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Lonestar Heart Center

Amarillo, Texas, 79106, United States

Location

Wheaton Franciscan Healthcare

Milwaukee, Wisconsin, 53215, United States

Location

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, 55401, United States

Location

Related Publications (3)

• 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.

  PMID: 25982108 RESULT

• 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.

  PMID: 29705650 DERIVED

• 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.

  PMID: 26011593 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Zile, MD

  Medical University of South Carolina

  STUDY CHAIR

• William Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Fred Weaver, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Faiez Zannad, MD

  Inserm Centre d'Investigation, CHU de Nancy

  PRINCIPAL INVESTIGATOR

• JoAnn Lindenfield, MD

  Vanderbilt Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: March 1, 2021
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

US (23)