Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

Status: Unknown status
Location: See all (92) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this clinical trial (NCT02627196) 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, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT). The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:

• Age 21 years or above.

• Currently NYHA Class II or III heart failure. For NYHA Class II, must have been NYHA Class III at any point in time within 3 calendar months prior to enrollment or at time of screening (enrollment is defined as the date the subject provided written consent).

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

• Heart failure accompanied by either:

• Core lab NT-proBNP ≥ 400 AND <1600 pg/ml within 45 days prior to randomization OR

• Core lab NT-proBNP < 400 pg/ml within 45 days prior to randomization AND a heart failure hospitalization in the past 12 months.

• Note: Heart failure hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of heart failure or an emergency room visit with a primary diagnosis of heart failure.

• Note: Screening/Baseline core lab NT-proBNP must be collected in an outpatient setting at a time when the subject is thought to be clinically stable.

• 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:

• No more than a 100% increase or a 50% decrease of the dosage of any one medication other than a diuretic.

• Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.

• Unrestricted changes in diuretics are allowed as long as the subject remains on a diuretic.

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

• The artery planned for the BAROSTIM implant must meet both of the following criteria:

• 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 AND

• No ulcerative carotid arterial plaques AND

• No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal carotid AND

• No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the distal common carotid

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

• If female and of childbearing potential, must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization.

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

• Subjects implanted with a cardiac rhythm management device that does not utilize an intracardiac lead, or implanted with a neurostimulation device, must be approved by the CVRx Clinical department.

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

Locations
United States
Arkansas
Washington Regional Medical Center
Fayetteville
Arizona
Heart and Rhythm Solutions, PLLC
Chandler
Chan Heart Rhythm Institute
Mesa
Arizona Arrhythmia Research Center
Phoenix
Cardiovascular Consultants, Ltd.
Phoenix
Phoenix Cardiovascular Research Group
Phoenix
California
Central Cardiology Medical Center
Bakersfield
Chula Vista Cardiac Center
Chula Vista
Sharp Chula Vista Medical Center
Chula Vista
Sharp Grossmont
Chula Vista
John Muir Health Clinical Research Center
Concord
Herndon Surgery Center
Fresno
University of California, San Francisco - Fresno
Fresno
Glendale Adventist Medical Center
Glendale
Memorial Health Services
Laguna Hills
Los Alamitos Cardiovascular
Los Alamitos
Southern California Permanente Medical Group
Los Angeles
University of Southern California
Los Angeles
Advanced Cardiovascular Specialists
Mountain View
Hoag Memorial Hospital
Newport Beach
UC Irvine Health
Orange
Desert Heart Regional Medical Center
Palm Springs
Huntington Hospital
Pasadena
Dignity Health
Sacramento
Adventist Heart Institute
Saint Helena
University of California San Francisco
San Francisco
Bonometti, Inc
Santa Barbara
Colorado
North Colorado Medical Center
Greeley
Medical Center of the Rockies Research
Loveland
Florida
Atlantic Clinical Research Center - Cardiology
Atlantis
Clearwater Cardiovascular Consultants
Clearwater
Holy Cross Hospital
Fort Lauderdale
Memorial Cardiovascular Institute
Hollywood
AdventHealth Orlando
Orlando
Avanza Medical Research Center
Pensacola
University of South Florida
Tampa
Georgia
Mercer University
Macon
WellStar Medical Group
Marietta
Idaho
St. Alphonsus Medical Center
Boise
Illinois
NorthShore University Health System
Evanston
Advocate Medical Group
Naperville
Prairie Education and Research Cooperative
Springfield
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Via Christi Research
Wichita
Kentucky
Baptist Health Lexington
Lexington
University of Kentucky
Lexington
Louisiana
Cardiovascular Institute of the South
Houma
Ochsner Clinic Foundation
New Orleans
Tulane University & Vascular Institute
New Orleans
Massachusetts
St. Elizabeth's Medical Center
Brighton
Michigan
Detroit Medical Center Cardiovascular Institute
Detroit
Ascension St. Mary's Research Institute
Saginaw
Providence-Providence Park Hospital
Southfield
Missouri
Mercy Hospital St. Louis
Saint Louis
St. Louis Heart and Vascular
Saint Louis
Washington University
Saint Louis
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
Cone Health
Greensboro
WakeMed
Raleigh
Wake Forest Baptist Health
Winston-salem
Nebraska
Nebraska Heart Institute
Lincoln
New Jersey
Deborah Heart and Lung Center
Browns Mills
Hackensack University Medical Center
Hackensack
New Mexico
Presbyterian Heart Group
Albuquerque
Nevada
Healthcare Partners Clinical Research
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
New York
University of Rochester
Rochester
St. Francis Hospital - Long Island
Roslyn
Ohio
The Christ Hospital
Cincinnati
Ohio State University
Columbus
Oklahoma
Oklahoma Cardiovascular Research Group
Oklahoma City
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Drexel University
Philadelphia
Allegheny-Singer Research Institute
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
McLeod Cardiology Associates
Florence
Tennessee
Stern Cardiovascular Foundation
Germantown
Texas
Texas Cardiac Arrhythmia Research Foundation
Austin
Cardiovascular Research Institute of Dallas
Dallas
Private Practice Leadership
Houston
Methodist Richardson Medical Center
Richardson
Tyler Cardiovascular Consultants
Tyler
Utah
Intermountain Heart Institute
Murray
University of Utah
Salt Lake City
Washington
Virginia Mason Medical Center
Seattle
CHI Franciscan Health Research Center
Tacoma
Wisconsin
Columbia St. Mary's Hospital
Milwaukee
Other Locations
United Kingdom
Belfast Health & Social Care Trust
Belfast
Royal Papworth Hospital NHS Foundation Trust
Cambridge
Royal Brompton & Harefield NHS Foundation Trust
Harefield
Liverpool Heart and Chest Hospital
Liverpool
Time Frame
Start Date: April 19, 2016
Completion Date: December 2021
Participants
Target number of participants: 1200
Treatments
Experimental: Device and Medical Management
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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.
Authors
Shang-Chuin Lee, Liviu Klein, Wassim Shaheen, Vyshali Rao, Debra Weinstein, Timothy Vittorio, Mark Moshiyakhov, Leonardo Macias, Gery Tomassoni, Thomas Davis, Rajesh Banker, Charles Moore, German Larrain, Srinivas Murali, Elizabeth Juneman, Jalal Ghali, Nigel Gupta, Gregory Ewald, Robert Rho, Sanjay Deshpande, Nirav Raval, Rohit Amin, Gurusher Panjrath, Hetal Bhakta, David Singh, Anuj Jain, Vimal Rabdiya, Claudio Bonometti, Dhiraj Narula, George Kramer, Martin Berk, Joan Susie Woo, Arash Aryana, John George, Ashwani Bedi, Marilyn King, Joshua Larned, Jared Salvo, Pamela Craven, James Mudd, Colleen Johnson, John McKenzie, Rajesh Malik, Randy Lieberman, Dawn Lombardo, Brett Berman, Ryan Brown, Massimo Napolitano, Rami Kahwash, Amir Kashani, Thampi John, Thomas O'Brien, Michael Lauer, Andrew Sauer, Fred Weaver, Andrea Natale, Daniel Kaiser, Sibu Saha, Rodrigo Chan, Justin Roberts, David Zhang, Fadi Matar, Patrick Monteleone, Joel Carver, Gil Vardi, Heath Saltzman, Freddy Abi-Samra, Richard Kiel, Rita A Jermyn, Lana Tsao, Peter Fattal, Howard Eisen, Bryant Nguyen, Aaron Hesselson, Kenneth Deck, Rami Alharethi, Chowdhury Ahsan, Himal Shah, Marwan Bahu, Robert Berkowitz, Frank McGrew, Edward Gilbert, Maria Costanzo, Niya Jones, Patrick Green, Robert Schwartz, William Mellana, Lin-Wang Dong, Khaled Awad, Faiez Zannad, JoAnn Lindenfield, Christopher Cole, Steven Forman, Gilanthony Ungab, John Bisognano, Bing Liem, Adrian Van Bakel, Luanda Grazette, Vijay Swarup, James Allred, Prashant Bhave, Lin Wang Dong, Raul Torres, GilAnthony Vardi, Gil Ungab, Nasar Nallamothu, Rohit Amind, Robert Gordon, Rebecca Lane, Nathan Foster, William Abraham, Brian Howard, Marc Silver, Daniel Benhayon, Efrain Gonzalez, Ilyas Colombowala
Related Therapeutic Areas
Sponsors
Leads: CVRx, Inc.

This content was sourced from clinicaltrials.gov

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