Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1200 participants
INTERVENTIONAL
2016-04-19
2023-12-31
Brief Summary
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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.
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Baroreflex Activation Therapy in Heart Failure
NCT01484288
Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure
NCT03230643
BAROSTIM NEO System in the Treatment of Heart Failure
NCT01471860
BAROSTIM® Hope for Heart Failure Study
NCT01720160
Rheos® Diastolic Heart Failure Trial
NCT00718939
Detailed Description
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For all subjects, trial visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-implant (post anticipated implant for medical management). Visits will occur quarterly from 15 to 24 months and semi-annually thereafter.
Subjects are followed in an identical manner regardless of trial arm.
The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence of morbidity and mortality benefit. This trial will involve one or more interim analyses to evaluate when sufficient evidence is reached for the final morbidity and mortality analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
BAROSTIM NEO® System
Medical Management
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.
Medical Management
Interventions
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BAROSTIM NEO® System
Medical Management
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
4. 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.
5. 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.
6. Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to randomization.
7. 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:
1. Below the level of the mandible AND
2. No ulcerative carotid arterial plaques AND
3. No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal carotid AND
4. 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.
8. 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.
9. 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.
10. 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.
11. Signed a CVRx-approved informed consent form for participation in this trial.
Exclusion Criteria
1. Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT.
2. 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. ,
3. Known or suspected baroreflex failure or autonomic neuropathy.
4. AHA/ACC Stage D heart failure within 45 days prior to randomization.
5. Body mass index \> 40.
6. Serum estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m2 within 45 days prior to randomization.
7. 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.)
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. This includes pacemaker or ICD implants or battery replacements.
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 (e.g. CABG or PTCA)
* 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 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 (e.g. cardiac amyloidosis).
19. Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use).
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 (e.g. recent drug abuse).
25. Enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical trial unless approved by the CVRx Clinical department.
26. Subjects with known allergies to silicone and titanium.
21 Years
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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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
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Heart and Rhythm Solutions, PLLC
Chandler, Arizona, United States
Chan Heart Rhythm Institute
Mesa, Arizona, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Cardiovascular Consultants, Ltd.
Phoenix, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
Central Cardiology Medical Center
Bakersfield, California, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Sharp Grossmont
Chula Vista, California, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
John Muir Health Clinical Research Center
Concord, California, United States
University of California, San Francisco - Fresno
Fresno, California, United States
Herndon Surgery Center
Fresno, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Memorial Health Services
Laguna Hills, California, United States
Los Alamitos Cardiovascular
Los Alamitos, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Advanced Cardiovascular Specialists
Mountain View, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
UC Irvine Health
Orange, California, United States
Desert Heart Regional Medical Center
Palm Springs, California, United States
Huntington Hospital
Pasadena, California, United States
Dignity Health
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Bonometti, Inc
Santa Barbara, California, United States
Adventist Heart Institute
St. Helena, California, United States
North Colorado Medical Center
Greeley, Colorado, United States
Medical Center of the Rockies Research
Loveland, Colorado, United States
Atlantic Clinical Research Center - Cardiology
Atlantis, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Cardiovascular Institute
Hollywood, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States
Mercer University
Macon, Georgia, United States
WellStar Medical Group
Marietta, Georgia, United States
St. Alphonsus Medical Center
Boise, Idaho, United States
NorthShore University Health System
Evanston, Illinois, United States
Advocate Medical Group
Naperville, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Via Christi Research
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Tulane University & Vascular Institute
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Detroit Medical Center Cardiovascular Institute
Detroit, Michigan, United States
Ascension St. Mary's Research Institute
Saginaw, Michigan, United States
Providence-Providence Park Hospital
Southfield, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Washington University
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Healthcare Partners Clinical Research
Las Vegas, Nevada, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
St. Francis Hospital - Long Island
Roslyn, New York, United States
Cone Health
Greensboro, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Drexel University
Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Cardiology Associates
Florence, South Carolina, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States
Private Practice Leadership
Houston, Texas, United States
Methodist Richardson Medical Center
Richardson, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Intermountain Heart Institute
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
CHI Franciscan Health Research Center
Tacoma, Washington, United States
Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
Harefield, Middlesex, United Kingdom
Belfast Health & Social Care Trust
Belfast, Northern Ireland, United Kingdom
Countries
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References
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Fu Q, Zhang R, Witkowski S, Arbab-Zadeh A, Prasad A, Okazaki K, Levine BD. Persistent sympathetic activation during chronic antihypertensive therapy: a potential mechanism for long term morbidity? Hypertension. 2005 Apr;45(4):513-21. doi: 10.1161/01.HYP.0000158312.63381.c1. Epub 2005 Feb 28.
Esler M, Kaye D. Increased sympathetic nervous system activity and its therapeutic reduction in arterial hypertension, portal hypertension and heart failure. J Auton Nerv Syst. 1998 Oct 15;72(2-3):210-9. doi: 10.1016/s0165-1838(98)00107-6.
Sleight P. The importance of the autonomic nervous system in health and disease. Aust N Z J Med. 1997 Aug;27(4):467-73. doi: 10.1111/j.1445-5994.1997.tb02220.x.
Peters TK, Koralewski HE, Zerbst E. Blood pressure and heart rate changes during physical activity upon heart rate feedback-controlled electrical carotid sinus nerve stimulation. Int J Cardiol. 1989 Mar;22(3):389-92. doi: 10.1016/0167-5273(89)90281-7.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Sponsor Website
Study Website
Other Identifiers
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360043-001
Identifier Type: -
Identifier Source: org_study_id
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