BAROSTIM® Hope for Heart Failure Study

NCT ID: NCT01720160

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2021-03-31

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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device

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.

Group Type: EXPERIMENTAL

BAROSTIM NEO® System

Intervention Type: DEVICE

Implant procedure

Standard of care medical managment therapy for heart failure

Intervention Type: 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.

Medical Management

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.

Group Type: ACTIVE_COMPARATOR

Standard of care medical managment therapy for heart failure

Intervention Type: 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.

Interventions

BAROSTIM NEO® System

Implant procedure

Intervention Type: DEVICE

Standard of care medical managment therapy for heart failure

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.

Intervention Type: OTHER

Other Intervention Names

Neo® System

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Zile, MD

Role: STUDY_CHAIR

Medical University of South Carolina

William Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Fred Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Faiez Zannad, MD

Role: PRINCIPAL_INVESTIGATOR

Inserm Centre d'Investigation, CHU de Nancy

JoAnn Lindenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Heart and Vascular Institute

Locations

Southwest Cardiovascular Associates

Mesa, Arizona, United States

Arizona Heart Rhythm Research Center

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

George Washington University

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

ACRC - Cardiology

Atlantis, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Advocate Medical Group

Naperville, Illinois, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

St Elizabeth's Medical Center

Brighton, Massachusetts, United States

Mid-Michigan Medical Center Midland

Midland, Michigan, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

The Ohio State University

Columbus, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Lonestar Heart Center

Amarillo, Texas, United States

Wheaton Franciscan Healthcare

Milwaukee, Wisconsin, United States

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25982108 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29705650 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26011593 (View on PubMed)

Other Identifiers

360032-001

Identifier Type: -

Identifier Source: org_study_id