HOPE4HF: BAROSTIM® Hope for Heart Failure Study

Sponsor

CVRx, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01720160

Collaborator

(none)

Enrollment

Locations

Arms

99.9

Duration (Months)

4.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: BAROSTIM NEO® System Other: Standard of care medical managment therapy for heart failure	N/A

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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Barostim HOPE4HF Study

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: BAROSTIM NEO® System Implant procedure Other Names: Neo® System Other: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: BAROSTIM NEO® System

Implant procedure

Other Names:

Neo® System

Other: 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.

Active Comparator: 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.

Other: Standard of care medical managment therapy for heart failure

Outcome Measures

Primary Outcome Measures

Heart failure metric improvements from baseline [12 months]
To describe changes in measures compared to baseline.
System and procedure related adverse events [6 months]
To demonstrate the safety of the Neo system in a heart failure population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Cardiovascular Associates	Mesa	Arizona	United States	85206
2	Arizona Heart Rhythm Research Center	Phoenix	Arizona	United States	53226
3	University of Southern California	Los Angeles	California	United States	90033
4	George Washington University	Washington	District of Columbia	United States	20037
5	ACRC - Cardiology	Atlantis	Florida	United States	33462
6	AdventHealth Orlando	Orlando	Florida	United States	32803
7	Tampa General Hospital	Tampa	Florida	United States	33606
8	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
9	Advocate Medical Group	Naperville	Illinois	United States	60540
10	Cardiovascular Institute of the South	Houma	Louisiana	United States	70360
11	St Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135
12	Mid-Michigan Medical Center Midland	Midland	Michigan	United States	48670
13	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan	United States	49770
14	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
15	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
16	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
17	The Ohio State University	Columbus	Ohio	United States	43210
18	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma	United States	73120
19	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
20	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
21	Lonestar Heart Center	Amarillo	Texas	United States	79106
22	Wheaton Franciscan Healthcare	Milwaukee	Wisconsin	United States	53215
23	Aspirus Heart & Vascular Institute	Wausau	Wisconsin	United States	55401

Sponsors and Collaborators

CVRx, Inc.

Investigators

Study Chair: Michael Zile, MD, Medical University of South Carolina
Principal Investigator: 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