[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":307,"collaborators":309,"id":316,"slug":317,"hasResults":318,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":318,"sex":324,"minAge":325,"maxAge":25,"enrollmentInfo":326,"targetDuration":25,"studyType":329,"phases":330,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},{"fullName":5,"class":6},"Axon Therapies, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Greater Splanchnic Nerve Ablation","ACTIVE_COMPARATOR","After anesthesia is given, doctors will use the Satera Ablation System to reach a nerve called the right greater splanchnic nerve. Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.",[13],"Device: Greater Splanchnic Nerve Ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Control Arm","SHAM_COMPARATOR","After anesthesia is given, doctors will place a small tube into a vein. The steps and length of the procedure will be similar to the Axon treatment procedure, but the study treatment will not be performed.",[19],"Device: Sham Control",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham Control","During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.",[15],[31],{"name":32,"affiliation":33,"role":34},"Sanjiv S Shah, MD","Northwestern University","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Judit Adorjan","CONTACT","16507221119","j.adorjan@axontherapies.com",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},"Jennifer Moore, MS","jennifer@axontherapies.com",[45,59,70,80,97,113,125,134,144,160,173,189,205,220,226,235,249,265,281,297],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":25},"Cardiology PC","COMPLETED","Birmingham","Alabama","35211","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.80249,33.52066,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":25},"Arizona Cardiovascular Research Center","ACTIVE_NOT_RECRUITING","Phoenix","Arizona","85016",{"type":54,"coordinates":66},[67,68],-112.07404,33.44838,{"lat":68,"lon":67},{"facility":71,"status":61,"city":72,"state":73,"zip":74,"country":51,"countryCode":52,"cosmosGeoPoint":75,"geoPoint":79,"contacts":25},"Scripps Health","La Jolla","California","92037",{"type":54,"coordinates":76},[77,78],-117.2742,32.84727,{"lat":78,"lon":77},{"facility":81,"status":82,"city":83,"state":73,"zip":84,"country":51,"countryCode":52,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University of California, San Francisco","RECRUITING","San Francisco","94143",{"type":54,"coordinates":86},[87,88],-122.41942,37.77493,{"lat":88,"lon":87},[91,95],{"name":92,"role":38,"phone":93,"phoneExt":25,"email":94},"Priscilla Zhang","415-514-7903","Priscilla.Zhang@ucsf.edu",{"name":96,"role":34,"phone":25,"phoneExt":25,"email":25},"Liviu Klein, MD",{"facility":98,"status":82,"city":99,"state":100,"zip":101,"country":51,"countryCode":52,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Bluhm Cardiovascular Institute of Northwestern University","Chicago","Illinois","60611",{"type":54,"coordinates":103},[104,105],-87.65005,41.85003,{"lat":105,"lon":104},[108,111],{"name":109,"role":38,"phone":25,"phoneExt":25,"email":110},"Daniel Roshevsky","droshevs@nm.org",{"name":112,"role":34,"phone":25,"phoneExt":25,"email":25},"Ravi Patel, MD",{"facility":114,"status":82,"city":99,"state":100,"zip":115,"country":51,"countryCode":52,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"University of Chicago Medical Center","60637",{"type":54,"coordinates":117},[104,105],{"lat":105,"lon":104},[120,123],{"name":121,"role":38,"phone":25,"phoneExt":25,"email":122},"Adaeze Emeka","adaeze.emeka@bsd.uchicago.edu",{"name":124,"role":34,"phone":25,"phoneExt":25,"email":25},"Mark Nathan Belkin, MD",{"facility":126,"status":61,"city":127,"state":100,"zip":128,"country":51,"countryCode":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":25},"Prairie Education and Research Cooperative","Springfield","62701",{"type":54,"coordinates":130},[131,132],-89.64371,39.80172,{"lat":132,"lon":131},{"facility":135,"status":47,"city":136,"state":137,"zip":138,"country":51,"countryCode":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":25},"Ascension St. Vincent - Cardiovascular Research Institute","Indianapolis","Indiana","46260",{"type":54,"coordinates":140},[141,142],-86.15804,39.76838,{"lat":142,"lon":141},{"facility":145,"status":82,"city":146,"state":147,"zip":148,"country":51,"countryCode":52,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"type":54,"coordinates":150},[151,152],-90.71953,29.59577,{"lat":152,"lon":151},[155,158],{"name":156,"role":38,"phone":25,"phoneExt":25,"email":157},"Kimberly Lirette","kimberly.lirette@cardio.com",{"name":159,"role":34,"phone":25,"phoneExt":25,"email":25},"Peter Fail, MD",{"facility":161,"status":82,"city":162,"state":163,"zip":164,"country":51,"countryCode":52,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Michigan Medicine, University of Michigan","Ann Arbor","Michigan","48109",{"type":54,"coordinates":166},[167,168],-83.74088,42.27756,{"lat":168,"lon":167},[171],{"name":172,"role":34,"phone":25,"phoneExt":25,"email":25},"Scott Hummel, MD",{"facility":174,"status":82,"city":175,"state":176,"zip":177,"country":51,"countryCode":52,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Mayo Clinic","Rochester","Minnesota","55905",{"type":54,"coordinates":179},[180,181],-92.4699,44.02163,{"lat":181,"lon":180},[184,187],{"name":185,"role":38,"phone":25,"phoneExt":25,"email":186},"Alyssa Ploof","ploof.alyssa@mayo.edu",{"name":188,"role":34,"phone":25,"phoneExt":25,"email":25},"Barry Borlaug, MD",{"facility":190,"status":82,"city":191,"state":192,"zip":193,"country":51,"countryCode":52,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"St. Louis Heart and Vascular","St Louis","Missouri","63136",{"type":54,"coordinates":195},[196,197],-90.19789,38.62727,{"lat":197,"lon":196},[200,203],{"name":201,"role":38,"phone":25,"phoneExt":25,"email":202},"Melissa McCann","mmccann@slhv.com",{"name":204,"role":34,"phone":25,"phoneExt":25,"email":25},"Gil Vardi, MD",{"facility":206,"status":82,"city":207,"state":207,"zip":208,"country":51,"countryCode":52,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Weill Cornell Medicine","New York","10021",{"type":54,"coordinates":210},[211,212],-74.00597,40.71427,{"lat":212,"lon":211},[215,218],{"name":216,"role":38,"phone":25,"phoneExt":25,"email":217},"Caroline Goldstein","cag4020@med.cornell.edu",{"name":219,"role":34,"phone":25,"phoneExt":25,"email":25},"Parag Goyal, MD",{"facility":221,"status":61,"city":207,"state":207,"zip":222,"country":51,"countryCode":52,"cosmosGeoPoint":223,"geoPoint":225,"contacts":25},"Icahn School of Medicine at Mount Sinai","10029",{"type":54,"coordinates":224},[211,212],{"lat":212,"lon":211},{"facility":227,"status":82,"city":207,"state":207,"zip":228,"country":51,"countryCode":52,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Columbia University Medical Center","10032",{"type":54,"coordinates":230},[211,212],{"lat":212,"lon":211},[233],{"name":234,"role":34,"phone":25,"phoneExt":25,"email":25},"Nir Uriel, MD",{"facility":236,"status":82,"city":175,"state":207,"zip":237,"country":51,"countryCode":52,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Rochester General Hospital","14621",{"type":54,"coordinates":239},[240,241],-77.61556,43.15478,{"lat":241,"lon":240},[244,247],{"name":245,"role":38,"phone":25,"phoneExt":25,"email":246},"Kathleen Ebeling, RN","kathleen.ebeling@rochesterregional.org",{"name":248,"role":34,"phone":25,"phoneExt":25,"email":25},"Scott Feitell, DO",{"facility":250,"status":82,"city":251,"state":252,"zip":253,"country":51,"countryCode":52,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Duke University Medical Center","Durham","North Carolina","27710",{"type":54,"coordinates":255},[256,257],-78.89862,35.99403,{"lat":257,"lon":256},[260,263],{"name":261,"role":38,"phone":25,"phoneExt":25,"email":262},"Matthew Gray","james.gray@duke.edu",{"name":264,"role":34,"phone":25,"phoneExt":25,"email":25},"Marat Fudim, MD, MHS",{"facility":266,"status":82,"city":267,"state":268,"zip":269,"country":51,"countryCode":52,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":54,"coordinates":271},[272,273],-82.99879,39.96118,{"lat":273,"lon":272},[276,279],{"name":277,"role":38,"phone":25,"phoneExt":25,"email":278},"Kalyn Ferguson","kalyn.ferguson@osumc.edu",{"name":280,"role":34,"phone":25,"phoneExt":25,"email":25},"Alexandria Miller, MD",{"facility":282,"status":82,"city":283,"state":284,"zip":285,"country":51,"countryCode":52,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":54,"coordinates":287},[288,289],-79.93275,32.77632,{"lat":289,"lon":288},[292,295],{"name":293,"role":38,"phone":25,"phoneExt":25,"email":294},"Elly Borhanian","borhania@musc.edu",{"name":296,"role":34,"phone":25,"phoneExt":25,"email":25},"Sheldon Litwin, MD",{"facility":298,"status":61,"city":299,"state":300,"zip":301,"country":51,"countryCode":52,"cosmosGeoPoint":302,"geoPoint":306,"contacts":25},"Virginia Commonwealth University Medical Center","Richmond","Virginia","23298",{"type":54,"coordinates":303},[304,305],-77.46026,37.55376,{"lat":305,"lon":304},{"type":308,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[310,313,315],{"name":311,"class":312},"NAMSA","OTHER",{"name":314,"class":312},"Cardiovascular Research Foundation, New York",{"name":33,"class":312},"100407977","endovascular-ablation-of-the-right-greater-splanchnic-nerve-in-subjects-having-hfpef-100407977",false,"NCT04592445","Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF","Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction: Randomized Controlled Feasibility Trial - The Rebalance HF Study","Rebalance-HF","Inclusion Criteria\n\n1. Chronic heart failure, defined as:\n\n   1. Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for \\>30 days, AND\n   2. NYHA class II with a history of \\>NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND\n   3. At least one of the following:\n\n   i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP \\>300 pg\u002Fml in normal sinus rhythm (\\>450 pg\u002Fml in atrial fibrillation or flutter) within the past 6 months; BNP \\>100 pg\u002Fml in normal sinus rhythm (\\>300 pg\u002Fml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.\n2. Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF\u002FAHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes \\[≥100% increase or ≥50% decrease\\] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.\n3. LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.\n4. Age ≥40 years.\n5. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.\n\nExclusion Criteria:\n\n1. MI (type I) and\u002For percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.\n2. Cardiac resynchronization therapy initiated within 3 months prior to screening.\n3. Advanced heart failure defined as one or more of the following:\n\n   1. ACC\u002FAHA\u002FESC Stage D HF or non-ambulatory NYHA Class IV HF.\n   2. Inotropic infusion (continuous or intermittent) within 6 months prior to screening.\n   3. Subject is on the cardiac transplant waiting list.\n   4. Presence of or prior history of mechanical circulatory support for HF.\n4. Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E\u002FA) ratio \\>2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.\n5. Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \\\u003C12 mm or right ventricular (RV) fractional area change (FAC) \\\u003C25% assessed by the screening echocardiogram.\n6. Body mass index (BMI) \\>45 kg\u002Fm2.\n7. 6-minute walk test distance \\\u003C100 meters OR \\>450 meters.\n8. Admission for HF within the 30 days prior to planned index procedure.\n9. Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of \\>20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.\n10. Orthostatic pulse pressure change from supine to standing decrease of \\>10mmHg in the absence of a HR increase \\>15bpm\n11. Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.\n12. Systolic BP \\\u003C100 mmHg or \\>170 mmHg despite appropriate medical management.\n13. Baseline screening ECG resting HR \\>100 beats per minute or ventricular tachycardia.\n14. Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.\n15. Left ventricular EF \\\u003C40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.\n16. Presence of significant valve disease defined by the site cardiologist as:\n\n    1. Greater than mild mitral valve stenosis.\n    2. Greater than moderate mitral valve regurgitation.\n    3. Greater than moderate-to-severe tricuspid valve regurgitation.\n    4. Greater than moderate aortic valve stenosis or regurgitation.\n17. Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).\n18. History of clinically significant liver cirrhosis.\n19. Prior weight loss surgery\n20. Dialysis dependent; or estimated GFR \\\u003C25 ml\u002Fmin\u002F1.73 m2 by CKD-EPI creatinine equation.\n21. Arterial oxygen saturation \\\u003C90% on room air.\n22. Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III or worse chronic obstructive pulmonary disease (COPD).\n23. Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.\n24. Life expectancy \\\u003C12 months for non-cardiovascular reasons.\n25. Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.\n26. Females who are pregnant or lactating or planning to become pregnant during the next year.\n27. Any of the following measured by screening right heart catheterization:\n\n    1. Mean right atrial pressure (RAP) \\>20 mmHg at rest\n    2. Cardiac index \\\u003C2.0 L\u002Fmin\u002Fm2 at rest\n    3. Pulmonary vascular resistance (PVR) \\>4 Wood units\n\n    Exclusion Criteria Assessed During the index procedure:\n28. Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the interventional device from the access site to target vessel. This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.","ALL","40 Years",{"count":327,"type":328},150,"ESTIMATED","INTERVENTIONAL",[331],"NA","The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.",[334],"Heart Failure With Preserved Ejection Fraction (HFpEF",[336,337,338,339],"Heart Failure with Preserved Ejection Fraction (HFpEF)","HFpEF","Greater Splanchnic Nerve","GSN","2026-03-10",{"date":342,"type":343},"2026-03-13","ACTUAL",{"date":345,"type":343},"2020-12-18",{"date":347,"type":328},"2029-08-10",{"name":5,"class":6},20]