Baroreflex Activation Therapy for Heart Failure

NCT02627196 | Completed Results DMC FDA Device

• 1 other identifier: 360043-001
• Study Type: interventional
• Target: 1,090
• Locations: 2 countries
• Sites: 92

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

• Rate of Cardiovascular Mortality and Heart Failure Morbidity

  To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant. Event rates were calculated using negative binomial to account for varying follow-up times. Rates are expressed as events per patient-year, with 95% confidence intervals reflecting dispersion.

  From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.

• Major Adverse Neurological and Cardiovascular Events (MANCE)

  To demonstrate the safety of the Barostim NEO® System via the event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 6 months post implant in the device arm.

  6 months post implant

• Percent Change in Log 10 Amino-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) From Baseline to 6 Months Post-implant

  To demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP from baseline to 6 months post-implant than medical management.

  6 months post-implant

• Change to Six Minute Hall Walk (6MHW)

  To demonstrate that treatment with the BAROSTIM NEO® system results in a larger improvement in 6MHW at 6 months than medical management. The 6 Minute Hall Walk is an assessment of a patient's functional exercise capacity by recording the maximum distance walked in 6 minutes on a flat course in meters (m). A higher score (more distance) indicates better functional capacity.

  Baseline and 6 months post-implant

• Change in Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) Score

  To demonstrate that treatment with the BAROSTIM NEO® System results in a larger improvement in MLWHF QOL score at 6 months than medical management. The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-reported outcome measure assessing the impact of heart failure on quality of life. It includes 21 items rated from 0 to 5 (0 = no impact, 5 = very much impact). The Total Score is the sum of all items and ranges from 0 to 105, with higher scores indicating worse quality of life.

  Baseline and 6 months post-implant

Study Arms (2)

Device and Medical Management

EXPERIMENTAL

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.

Device: BAROSTIM NEO® System; Drug: Medical Management

Medical Management

ACTIVE COMPARATOR

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.

Drug: Medical Management

Interventions

BAROSTIM NEO® System DEVICE

Device and Medical Management

Medical Management DRUG

Device and Medical Management; Medical Management

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• If any of the following criteria are met, subjects are not eligible for this trial.
• Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT.
• Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure. ,
• Known or suspected baroreflex failure or autonomic neuropathy.
• AHA/ACC Stage D heart failure within 45 days prior to randomization.
• Body mass index \> 40.
• Serum estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m2 within 45 days prior to randomization.
• Recurring resting heart rate of either \< 60 bpm or \> 100 bpm via clinic measurements within 45 days prior to randomization. (Note: Heart rate \<60 bpm is not applicable to subjects with an implanted device capable of pacing.)
• Recurring symptomatic hypotension within 45 days prior to randomization.
• Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular arrhythmias.
• Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the BAROSTIM NEO implant procedure. This includes pacemaker or ICD implants or battery replacements.
• Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior to randomization.
• Any of the following within 3 months of randomization:
• Myocardial infarction
• Unstable angina

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (92)

Heart and Rhythm Solutions, PLLC

Chandler, Arizona, 85286, United States

Location

Chan Heart Rhythm Institute

Mesa, Arizona, 85206, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Cardiovascular Consultants, Ltd.

Phoenix, Arizona, 85032, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

Central Cardiology Medical Center

Bakersfield, California, 93308, United States

Location

Chula Vista Cardiac Center

Chula Vista, California, 91910, United States

Location

Sharp Grossmont

Chula Vista, California, 91911, United States

Location

Sharp Chula Vista Medical Center

Chula Vista, California, 91991, United States

Location

John Muir Health Clinical Research Center

Concord, California, 94520, United States

Location

University of California, San Francisco - Fresno

Fresno, California, 93701, United States

Location

Herndon Surgery Center

Fresno, California, 93720, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91204, United States

Location

Memorial Health Services

Laguna Hills, California, 92653, United States

Location

Los Alamitos Cardiovascular

Los Alamitos, California, 90720, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Advanced Cardiovascular Specialists

Mountain View, California, 94040, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

Desert Heart Regional Medical Center

Palm Springs, California, 92262, United States

Location

Huntington Hospital

Pasadena, California, 91105, United States

Location

Dignity Health

Sacramento, California, 95819, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Bonometti, Inc

Santa Barbara, California, 93101, United States

Location

Adventist Heart Institute

St. Helena, California, 94574, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Medical Center of the Rockies Research

Loveland, Colorado, 80538, United States

Location

Atlantic Clinical Research Center - Cardiology

Atlantis, Florida, 33462, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Memorial Cardiovascular Institute

Hollywood, Florida, 33021, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Mercer University

Macon, Georgia, 31201, United States

Location

WellStar Medical Group

Marietta, Georgia, 30060, United States

Location

St. Alphonsus Medical Center

Boise, Idaho, 83704, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Advocate Medical Group

Naperville, Illinois, 60540, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

Via Christi Research

Wichita, Kansas, 67214, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Tulane University & Vascular Institute

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, 48201, United States

Location

Ascension St. Mary's Research Institute

Saginaw, Michigan, 48602, United States

Location

Providence-Providence Park Hospital

Southfield, Michigan, 48075, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Healthcare Partners Clinical Research

Las Vegas, Nevada, 89169, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

St. Francis Hospital - Long Island

Roslyn, New York, 11576, United States

Location

Cone Health

Greensboro, North Carolina, 27401, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Cardiology Associates

Florence, South Carolina, 29506, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Private Practice Leadership

Houston, Texas, 77094, United States

Location

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

Intermountain Heart Institute

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

CHI Franciscan Health Research Center

Tacoma, Washington, 98405, United States

Location

Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53211, United States

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Belfast Health & Social Care Trust

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Related Publications (21)

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• Georgakopoulos D, Wagner D, Cates AW, Irwin E, Lovett EG. Effects of electrical stimulation of the carotid sinus baroreflex using the Rheos device on ventricular-vascular coupling and myocardial efficiency assessed by pressure-volume relations in non-vagotomized anesthetized dogs. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:2025-9. doi: 10.1109/IEMBS.2009.5334421.

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• Sabbah HN, Gupta RC, Imai M, Irwin ED, Rastogi S, Rossing MA, Kieval RS. Chronic electrical stimulation of the carotid sinus baroreflex improves left ventricular function and promotes reversal of ventricular remodeling in dogs with advanced heart failure. Circ Heart Fail. 2011 Jan;4(1):65-70. doi: 10.1161/CIRCHEARTFAILURE.110.955013. Epub 2010 Nov 19.

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• Zucker IH, Hackley JF, Cornish KG, Hiser BA, Anderson NR, Kieval R, Irwin ED, Serdar DJ, Peuler JD, Rossing MA. Chronic baroreceptor activation enhances survival in dogs with pacing-induced heart failure. Hypertension. 2007 Nov;50(5):904-10. doi: 10.1161/HYPERTENSIONAHA.107.095216. Epub 2007 Sep 10.

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• 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 BACKGROUND

• Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2.

  PMID: 28043438 BACKGROUND

• Ferreira JP, Duarte K, Graves TL, Zile MR, Abraham WT, Weaver FA, Lindenfeld J, Zannad F. Natriuretic Peptides, 6-Min Walk Test, and Quality-of-Life Questionnaires as Clinically Meaningful Endpoints in HF Trials. J Am Coll Cardiol. 2016 Dec 20;68(24):2690-2707. doi: 10.1016/j.jacc.2016.09.936.

  PMID: 27978953 BACKGROUND

• 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 BACKGROUND

• Gronda E, Francis D, Zannad F, Hamm C, Brugada J, Vanoli E. Baroreflex activation therapy: a new approach to the management of advanced heart failure with reduced ejection fraction. J Cardiovasc Med (Hagerstown). 2017 Sep;18(9):641-649. doi: 10.2459/JCM.0000000000000544.

  PMID: 28737621 BACKGROUND

• Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28.

  PMID: 25067799 BACKGROUND

• Zile MR, Claggett BL, Prescott MF, McMurray JJ, Packer M, Rouleau JL, Swedberg K, Desai AS, Gong J, Shi VC, Solomon SD. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2425-2436. doi: 10.1016/j.jacc.2016.09.931.

  PMID: 27908347 BACKGROUND

• Cleland JG, McMurray JJ, Kjekshus J, Cornel JH, Dunselman P, Fonseca C, Hjalmarson A, Korewicki J, Lindberg M, Ranjith N, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Study Group. Plasma concentration of amino-terminal pro-brain natriuretic peptide in chronic heart failure: prediction of cardiovascular events and interaction with the effects of rosuvastatin: a report from CORONA (Controlled Rosuvastatin Multinational Trial in Heart Failure). J Am Coll Cardiol. 2009 Nov 10;54(20):1850-9. doi: 10.1016/j.jacc.2009.06.041.

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• Anand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011 Sep;4(5):569-77. doi: 10.1161/CIRCHEARTFAILURE.111.962654. Epub 2011 Jun 29.

  PMID: 21715583 BACKGROUND

• Anand IS, Claggett B, Liu J, Shah AM, Rector TS, Shah SJ, Desai AS, O'Meara E, Fleg JL, Pfeffer MA, Pitt B, Solomon SD. Interaction Between Spironolactone and Natriuretic Peptides in Patients With Heart Failure and Preserved Ejection Fraction: From the TOPCAT Trial. JACC Heart Fail. 2017 Apr;5(4):241-252. doi: 10.1016/j.jchf.2016.11.015.

  PMID: 28359411 BACKGROUND

• Fruhwald FM, Fahrleitner-Pammer A, Berger R, Leyva F, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC, Cleland JG. Early and sustained effects of cardiac resynchronization therapy on N-terminal pro-B-type natriuretic peptide in patients with moderate to severe heart failure and cardiac dyssynchrony. Eur Heart J. 2007 Jul;28(13):1592-7. doi: 10.1093/eurheartj/ehl505. Epub 2007 Feb 13.

  PMID: 17298973 BACKGROUND

• Zile MR, Abraham WT, Lindenfeld J, Weaver FA, Zannad F, Graves T, Rogers T, Galle EG. First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF. Am Heart J. 2018 Oct;204:139-150. doi: 10.1016/j.ahj.2018.07.011. Epub 2018 Jul 22.

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• Lindenfeld J, Gupta R, Grazette L, Ruddy JM, Tsao L, Galle E, Rogers T, Sears S, Zannad F. Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure. JACC Heart Fail. 2021 Jun;9(6):430-438. doi: 10.1016/j.jchf.2021.01.012. Epub 2021 May 12.

  PMID: 33992562 DERIVED

• Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.

  PMID: 32616150 DERIVED

Related Links

• Sponsor Website
• Study Website

MeSH Terms

Conditions

Heart Failure

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Seth Wilks, PhD, Senior Director, Clinical Science
• Organization: CVRx, Inc.

swilks@cvrx.com

763-416-2840

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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: December 7, 2015
• First Posted: December 10, 2015
• Study Start: April 19, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); US (88)