Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:11/22/2018
Start Date:April 2016
End Date:April 2021

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The purpose of this trial is to develop valid scientific evidence for safety and
effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects
with heart failure, defined as New York Heart Association (NYHA) functional class III and
left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate
heart failure guideline directed therapy, excluding subjects eligible for or actively
receiving Cardiac Resynchronization Therapy (CRT).


Inclusion Criteria:

1. Currently NYHA Class II or III heart failure.

2. Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.

3. Heart failure accompanied by a BNP ≥ 100 or NT-proBNP ≥ 400 within 45 days prior to
randomization, or a heart failure hospitalization in the past 12 months

4. On optimal, stable, Guideline Directed Medical Therapy (GDMT) per country specific
guidelines for the treatment of heart-failure throughout screening/baseline evaluation
and for at least 4 weeks prior to obtaining any post-consent screening parameters.

5. Six-minute hall walk (6MHW) ≥ 150m AND ≤ 400m within 45 days prior to randomization.

6. The artery planned for the BAROSTIM implant must have:

- At least one carotid bifurcation as identification by a bilateral carotid duplex
ultrasound within 6 months prior to randomization that is:

- Below the level of the mandible

- Has no ulcerative carotid arterial plaques

- Has no carotid atherosclerosis producing at 50% or greater reduction in
linear diameter of the internal carotid

- Has no carotid atherosclerosis producing at 50% or greater reduction in
linear diameter of the distal common carotid

- No prior surgery, radiation, or endovascular stent placement in the carotid
artery or the carotid sinus region.

7. If female and of childbearing potential, must use a medically accepted method of birth
control and have a negative pregnancy test within 14 days of randomization.

8. Received a standard cardiac work up and is an appropriate candidate for the study and
the surgical procedure as determine by a trial cardiologist and trial surgeon.

9. Subjects implanted with a cardiac rhythm management device that does not utilize an
intracardiac lead, or implanted with a neurostimulation device, must be approved prior
to enrollment.

10. Signed a CVRx-approved informed consent form for participation in this trial.

Exclusion Criteria:

1. Received cardiac resynchronization therapy (CRT) within 6 months of randomization, or
is actively receiving CRT.

2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT)
device according to the American Heart Association/American College of
Cardiology/European Society of Cardiology (AHA/ACC/ESC) guidelines for the treatment
of congestive heart failure.

3. Known or suspected baroreflex failure or autonomic neuropathy.

4. AHA/ACC Stage D heart failure within 45 days prior to randomization.

5. BMI > 40.

6. Serum estimated glomerular filtration rate (eGFR) < 25 mL/min/173m^2 within 45 days
prior to randomization.

7. Recurring resting heart rate of either < 60 beats per minute(bpm) or > 100 bpm via
clinic measurements within 45 days prior to randomization. (Heart rate of < 60bpm is
not applicable to subjects with an implanted device capable of pacing).

8. Recurring symptomatic hypotension within 45 days prior to randomization.

9. Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular
arrhythmias.

10. Subjects with any surgery that has occurred, or is planned to occur, within 45 days of
the BAROSTIM NEO® implant procedure.

11. Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior
to randomization.

12. Any of the following within 3 months of randomization:

- Myocardial infarction

- Unstable angina

- Percutaneous coronary intervention

- Cerebral vascular accident or transient ischemic attack

- Sudden cardiac death

13. Solid organ or hematologic transplant, or currently being actively evaluated for an
organ transplant.

14. Has received or is receiving left ventricular assist device (LVAD) therapy.

15. Has received or is receiving chronic dialysis.

16. Heart failure secondary to a reversible cause, such as cardiac structural valvular
disease, acute myocarditis and pericardial constriction.

17. Primary pulmonary hypertension.

18. Infiltrative cardiomyopathy.

19. Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung
disease.

20. Active malignancy.

21. Current or planned treatment with intravenous positive inotrope therapy

22. Life expectancy less than one year.

23. Clinically significant psychological condition that, in the physician's opinion, would
prohibit the subject's ability to meet the protocol requirements.

24. Unable or unwilling to fulfill the protocol medication compliance, testing, and
follow-up requirements.

25. Enrolled and active in another clinical trial (unless previously approved by the CVRx
Clinical Department).

26. Subjects with known allergies to silicone and titanium
We found this trial at
84
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Joshua Larned
Phone: 954-2954-229-8571
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Charles Moore
Phone: 601-984-5678
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: Chowdhury Ahsan
Phone: 702-383-7842
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Luanda Grazette
Phone: 323-442-6863
University of Southern California The University of Southern California is one of the world’s leading...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: John Bisognano
Phone: 585-341-7764
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Edward Gilbert
Phone: 801-587-9048
University of Utah Research is a major component in the life of the U benefiting...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Fadi Matar
Phone: 813-259-0671
University of South Florida The University of South Florida is a high-impact, global research university...
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Albuquerque, New Mexico 87106
Principal Investigator: Leonardo Macias
Phone: 505-563-2716
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Atlantis, Florida 33462
Principal Investigator: Debra Weinstein
Phone: 561-964-7880
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Austin, Texas 78758
Principal Investigator: Andrea Natale
Phone: 512-458-9410
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2901 Sillect Avenue
Bakersfield, California 93308
Principal Investigator: Jared Salvo
Phone: 661-323-8384
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1055 North Curtis Road
Boise, Idaho 83704
Principal Investigator: Ilyas Colombowala
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Brighton, Massachusetts 02135
Principal Investigator: Lana Tsao
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Browns Mills, New Jersey 08015
Principal Investigator: Mark Moshiyakhov
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Chandler, Arizona 85286
Principal Investigator: Himal Shah
Phone: 480-383-3792
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Adrian Van Bakel
Phone: 843-792-1238
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Chula Vista, California 91910
Principal Investigator: Brett Berman
Phone: 619-934-3260
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Clearwater, Florida 33756
Principal Investigator: Marilyn King
Phone: 727-467-9393
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Rami Kahwash
Phone: 614-292-4084
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Concord, California 94520
Principal Investigator: Ryan Brown
Phone: 925-674-2580
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Dallas, Texas 75231
Principal Investigator: Martin Berk
Phone: 214-360-0869
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Detroit, Michigan
Principal Investigator: Randy Lieberman
Phone: 313-745-7050
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Evanston, Illinois 60201
Principal Investigator: Robert Gordon, MD
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Fayetteville, Arkansas 72703
Principal Investigator: Joel Carver
Phone: 479-463-7856
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101 Johns Street
Florence, South Carolina 29506
Principal Investigator: Rajesh Malik
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Fresno, California
Principal Investigator: Richard Kiel
Phone: 559-499-6566
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1843 East Fir Avenue
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Principal Investigator: Thampi John
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Germantown, Tennessee 38138
Principal Investigator: Frank McGrew
Phone: 901-271-4181
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Glendale, California 91206
Principal Investigator: John McKenzie
Phone: 818-409-8009
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
Principal Investigator: Lin Wang Dong
Phone: 970-392-2012
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301 Wendover Avenue East
Greensboro, North Carolina 27401
Principal Investigator: James Allred, MD
Phone: 336-832-3799
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Massimo Napolitano
Phone: 551-996-5722
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Hollywood, Florida 33021
Principal Investigator: Daniel Benhayon
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Houma, Louisiana 70360
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Houston, Texas 77094
Principal Investigator: Amir Kashani
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Kansas City, Kansas
Principal Investigator: Andrew Sauer
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24953 Paseo De Valencia
Laguna Hills, California 92653
Principal Investigator: Kenneth Deck
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Las Vegas, Nevada 89169
Principal Investigator: Dhiraj Narula
Phone: 702-933-9419
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Aaron Hesselson
Phone: 859-218-1644
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Lexington, Kentucky 40503
Principal Investigator: Gery Tomassoni, MD
Phone: 859-260-4484
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Lincoln, Nebraska 68526
Principal Investigator: Anuj Jain
Phone: 402-328-3939
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Los Alamitos, California 90720
Principal Investigator: Steven Forman
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Los Angeles, California 90027
Principal Investigator: Nigel Gupta
Phone: 323-783-7404
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6420 Dutchmans Parkway
Louisville, Kentucky 40205
Principal Investigator: Robert Schwartz
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Loveland, Colorado 80538
Principal Investigator: Patrick Green
Phone: 970-624-1684
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Macon, Georgia 31220
Principal Investigator: Jalal Ghali
Phone: 478-301-5813
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55 Whitcher Street
Marietta, Georgia 30060
Principal Investigator: Brian Howard
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Mesa, Arizona 85206
Principal Investigator: Rodrigo Chan
Phone: 480-773-2220
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Principal Investigator: Efrain Gonzalez
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Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Mountain View, California 94040
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Murray, Utah 84143
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New Orleans, Louisiana 70121
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New Orleans, Louisiana 70112
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Newport Beach, California 92663
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Oklahoma City, Oklahoma 73120
Principal Investigator: Pamela Craven
Phone: 405-608-1284
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Nirav Raval
Phone: 407-303-9983
Florida Hospital Florida Hospital is one of the country
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Papworth Everard, Cambridge
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100 West California Boulevard
Pasadena, California 91105
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Pensacola, Florida 32504
Principal Investigator: Rohit Amin
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Pensacola, Florida 32504
Principal Investigator: Rohit Amind
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Heath Saltzman
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Phoenix, Arizona
Principal Investigator: Marwan Bahu
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Srinivas Murali
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Portland, Oregon 97239
Principal Investigator: James Mudd
Phone: 503-418-1679
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Raleigh, North Carolina 27610
Principal Investigator: Marc Silver, MD
Phone: 919-231-6132
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Richardson, Texas 75082
Principal Investigator: John George
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Roslyn, New York 11576
Principal Investigator: Rita A Jermyn
Phone: 516-622-4528
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Sacramento, California 95819
Principal Investigator: Arash Aryana
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1015 South Washington Avenue
Saginaw, Michigan 48602
Principal Investigator: Peter Fattal
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Saint Helena, California 94574
Principal Investigator: Daniel Kaiser
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Saint Louis, Missouri 63110
Principal Investigator: Gregory Ewald
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Saint Louis, Missouri 63136
Principal Investigator: Gil Vardi
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Saint Louis, Missouri 63141
Principal Investigator: Khaled Awad
Phone: 314-251-2797
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34800 Bob Wilson Drive
San Diego, California 92123
Principal Investigator: Gil Ungab
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San Francisco, California 94143
Principal Investigator: Liviu Klein
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Seattle, Washington 98111
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16001 West Nine Mile Road
Southfield, Michigan 48075
Principal Investigator: Nathan Foster
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Springfield, Illinois 62701
Principal Investigator: Nasar Nallamothu
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1235 East Cherokee Street
Springfield, Missouri 65804
Principal Investigator: Shang-Chuin Lee
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1708 South Yakima Avenue
Tacoma, Washington 98405
Principal Investigator: David Zhang
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Tyler, Texas 75701
Principal Investigator: Raul Torres
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3311 East Murdock Street
Wichita, Kansas 67208
Principal Investigator: Wassim Shaheen
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Winston-Salem, North Carolina 27157
Principal Investigator: Prashant Bhave, MD
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