[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325930":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":49,"armGroups":54,"interventions":60,"overallOfficials":49,"centralContacts":65,"locations":75,"responsibleParty":296,"collaborators":49,"id":298,"slug":299,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":300,"sex":306,"minAge":307,"maxAge":49,"enrollmentInfo":308,"targetDuration":49,"studyType":311,"phases":312,"briefSummary":313,"conditions":314,"keywords":49,"overallStatus":211,"whyStopped":49,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of major cardiac\u002Fcerebrovascular\u002Frenal events and re-intervention (Safety Endpoint)","Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.","30 days",[14,18,22,25,29,32,35,38],{"measure":15,"description":16,"timeFrame":17},"Rate at which device is successfully implanted (Device Success)","Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.","Day 0",{"measure":19,"description":20,"timeFrame":21},"Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)","Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp\u002FQs values.","10 days post-op",{"measure":23,"description":24,"timeFrame":12},"Rate at which the procedure is successful without major cardiac\u002Fcerebrovascular\u002Frenal events and re-intervention (Clinical Success)","Procedural success without major adverse cardiac, cerebrovascular, renal events (MACCRE), and re-intervention for study device related complications at 30 days.",{"measure":26,"description":27,"timeFrame":28},"Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called \"Qp\u002FQs\", from Baseline to Follow Up","Change in Qp\u002FQs value from Baseline to Follow Up (3Month, 6Month)","3 months, 6 months",{"measure":30,"description":31,"timeFrame":28},"Improvement in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up","Improvement in PCWP value from Baseline to Follow Up (3Month, 6Month)",{"measure":33,"description":34,"timeFrame":28},"Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up","Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)",{"measure":36,"description":37,"timeFrame":28},"Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up","Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)",{"measure":39,"description":40,"timeFrame":28},"Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up","Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. \"TAPSE\", Tricuspid Annular Plane Excursion 2. \"TAPSE\u002FsPAP\", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)",[42],{"measure":43,"description":44,"timeFrame":45},"HFrEF Subgroup Analysis","Data obtained from the refined HFrEF subgroup will be analyzed according to the endpoints defined above, based on measurements available across all follow-up time points.","10 days post-op, 30 days, 3 months, 6 months",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":49,"timePerspective":49,"maskingInfo":51},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":52,"maskingDescription":49,"whoMasked":49},"NONE","The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.",[55],{"label":56,"type":57,"description":49,"interventionNames":58},"Edwards APTURE transcatheter shunt system","EXPERIMENTAL",[59],"Device: Edwards APTURE transcatheter shunt system",[61],{"type":62,"name":56,"description":63,"armGroupLabels":64,"otherNames":49},"DEVICE","Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.",[56],[66,71],{"name":67,"role":68,"phone":69,"phoneExt":49,"email":70},"Natalie Alon","CONTACT","949-250-1898","Natalie_Alon@edwards.com",{"name":72,"role":68,"phone":73,"phoneExt":49,"email":74},"Melissa Arteaga","949-250-2002","melissa_arteaga@edwards.com",[76,90,100,109,119,129,140,150,160,169,179,189,199,209,233,256,266,276,286],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":49},"UC San Diego Health","ACTIVE_NOT_RECRUITING","La Jolla","California","92037","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-117.2742,32.84727,{"lat":88,"lon":87},{"facility":91,"status":92,"city":93,"state":80,"zip":94,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":49},"Cedars Sinai Medical Center","WITHDRAWN","Los Angeles","90048",{"type":85,"coordinates":96},[97,98],-118.24368,34.05223,{"lat":98,"lon":97},{"facility":101,"status":78,"city":102,"state":80,"zip":103,"country":82,"countryCode":83,"cosmosGeoPoint":104,"geoPoint":108,"contacts":49},"University California San Francisco","San Francisco","94143",{"type":85,"coordinates":105},[106,107],-122.41942,37.77493,{"lat":107,"lon":106},{"facility":110,"status":92,"city":111,"state":112,"zip":113,"country":82,"countryCode":83,"cosmosGeoPoint":114,"geoPoint":118,"contacts":49},"University of Colorado","Aurora","Colorado","80045",{"type":85,"coordinates":115},[116,117],-104.83192,39.72943,{"lat":117,"lon":116},{"facility":120,"status":78,"city":121,"state":122,"zip":123,"country":82,"countryCode":83,"cosmosGeoPoint":124,"geoPoint":128,"contacts":49},"University of Florida Health - Jacksonville","Jacksonville","Florida","32209",{"type":85,"coordinates":125},[126,127],-81.65565,30.33218,{"lat":127,"lon":126},{"facility":130,"status":131,"city":132,"state":133,"zip":134,"country":82,"countryCode":83,"cosmosGeoPoint":135,"geoPoint":139,"contacts":49},"St. Vincent Medical Group","COMPLETED","Indianapolis","Indiana","46260",{"type":85,"coordinates":136},[137,138],-86.15804,39.76838,{"lat":138,"lon":137},{"facility":141,"status":78,"city":142,"state":143,"zip":144,"country":82,"countryCode":83,"cosmosGeoPoint":145,"geoPoint":149,"contacts":49},"Kansas University Medical Center","Kansas City","Kansas","66160",{"type":85,"coordinates":146},[147,148],-94.62746,39.11417,{"lat":148,"lon":147},{"facility":151,"status":78,"city":152,"state":153,"zip":154,"country":82,"countryCode":83,"cosmosGeoPoint":155,"geoPoint":159,"contacts":49},"Abbott Northwestern","Minneapolis","Minnesota","55407",{"type":85,"coordinates":156},[157,158],-93.26384,44.97997,{"lat":158,"lon":157},{"facility":161,"status":78,"city":162,"state":153,"zip":163,"country":82,"countryCode":83,"cosmosGeoPoint":164,"geoPoint":168,"contacts":49},"Mayo Clinic","Rochester","55905",{"type":85,"coordinates":165},[166,167],-92.4699,44.02163,{"lat":167,"lon":166},{"facility":170,"status":92,"city":171,"state":172,"zip":173,"country":82,"countryCode":83,"cosmosGeoPoint":174,"geoPoint":178,"contacts":49},"Morristown Medical Center","Morristown","New Jersey","07960",{"type":85,"coordinates":175},[176,177],-74.48154,40.79677,{"lat":177,"lon":176},{"facility":180,"status":78,"city":181,"state":182,"zip":183,"country":82,"countryCode":83,"cosmosGeoPoint":184,"geoPoint":188,"contacts":49},"Montefiore Medical Center","The Bronx","New York","10467",{"type":85,"coordinates":185},[186,187],-73.86641,40.84985,{"lat":187,"lon":186},{"facility":190,"status":131,"city":191,"state":192,"zip":193,"country":82,"countryCode":83,"cosmosGeoPoint":194,"geoPoint":198,"contacts":49},"Atrium Health","Charlotte","North Carolina","28203",{"type":85,"coordinates":195},[196,197],-80.84313,35.22709,{"lat":197,"lon":196},{"facility":200,"status":78,"city":201,"state":202,"zip":203,"country":82,"countryCode":83,"cosmosGeoPoint":204,"geoPoint":208,"contacts":49},"The Christ Hospital","Cincinnati","Ohio","45219",{"type":85,"coordinates":205},[206,207],-84.51439,39.12711,{"lat":207,"lon":206},{"facility":210,"status":211,"city":212,"state":202,"zip":213,"country":82,"countryCode":83,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"The Ohio State University Medical Center","RECRUITING","Columbus","43210",{"type":85,"coordinates":215},[216,217],-82.99879,39.96118,{"lat":217,"lon":216},[220,224,228,231],{"name":221,"role":68,"phone":222,"phoneExt":49,"email":223},"Elizabeth Eberle","614-293-7464","Elizabeth.Eberle@osumc.edu",{"name":225,"role":68,"phone":226,"phoneExt":49,"email":227},"Annie Kellum","614-366-8848","Annie.Kellum@osumc.edu",{"name":229,"role":230,"phone":49,"phoneExt":49,"email":49},"Scott Lilly, MD","PRINCIPAL_INVESTIGATOR",{"name":232,"role":230,"phone":49,"phoneExt":49,"email":49},"Rami Kahwash, MD",{"facility":234,"status":211,"city":235,"state":236,"zip":237,"country":82,"countryCode":83,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Oklahoma Heart Institute","Tulsa","Oklahoma","74104",{"type":85,"coordinates":239},[240,241],-95.99277,36.15398,{"lat":241,"lon":240},[244,248,252,254],{"name":245,"role":68,"phone":246,"phoneExt":49,"email":247},"Tamara Morton","918-574-9223","tamara.morton@hillcrest.com",{"name":249,"role":68,"phone":250,"phoneExt":49,"email":251},"Allyson O'Guin","918-574-9253","allyson.oguin@hillcrest.com",{"name":253,"role":230,"phone":49,"phoneExt":49,"email":49},"Kamran Muhammad, MD",{"name":255,"role":230,"phone":49,"phoneExt":49,"email":49},"Steven Stroud, MD",{"facility":257,"status":78,"city":258,"state":259,"zip":260,"country":82,"countryCode":83,"cosmosGeoPoint":261,"geoPoint":265,"contacts":49},"Oregon Health and Science University","Portland","Oregon","97239",{"type":85,"coordinates":262},[263,264],-122.67621,45.52345,{"lat":264,"lon":263},{"facility":267,"status":131,"city":268,"state":269,"zip":270,"country":82,"countryCode":83,"cosmosGeoPoint":271,"geoPoint":275,"contacts":49},"Lankenau Institute for Medical Research","Wynnewood","Pennsylvania","19096",{"type":85,"coordinates":272},[273,274],-75.27074,40.00289,{"lat":274,"lon":273},{"facility":277,"status":78,"city":278,"state":279,"zip":280,"country":82,"countryCode":83,"cosmosGeoPoint":281,"geoPoint":285,"contacts":49},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":85,"coordinates":282},[283,284],-79.93275,32.77632,{"lat":284,"lon":283},{"facility":287,"status":78,"city":288,"state":289,"zip":290,"country":82,"countryCode":83,"cosmosGeoPoint":291,"geoPoint":295,"contacts":49},"Swedish Medical Center","Seattle","Washington","98122",{"type":85,"coordinates":292},[293,294],-122.33207,47.60621,{"lat":294,"lon":293},{"type":297,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100325930","early-feasibility-study---edwards-apture-transcatheter-shunt-system-100325930",false,"NCT03523416","Early Feasibility Study - Edwards APTURE Transcatheter Shunt System","Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)","ALT-FLOW US","Refined HFrEF Subgroup Inclusion Criteria:\n\n* A primary diagnosis of HFrEF (LVEF ≤ 40%), and\n* NYHA Class II, III, or IVa heart failure symptoms and\n* Documentation of at least one of the following in the past 12 months, such as:\n\n  * Hospitalization for heart failure; or\n  * Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.\n  * Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.\n\nNote: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.\n\n* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)\n\nRefined HFrEF Subgroup Exclusion Criteria:\n\n* Severe HF defined as one or more of the following:\n\n  * Ambulatory NT-proBNP value \\>5,000 pg\u002Fml or BNP value \\>1,600 pg\u002Fml\n  * Left ventricular end-diastolic diameter (LVEDD) \\>8 cm\n  * Left ventricular ejection fraction (LVEF) \\\u003C 20%\n  * ACC\u002FAHA Stage D HF or non-ambulatory NYHA Class IV HF\n  * Inotropic infusion (continuous or intermittent) within the past 6 months\n  * Active listing on the cardiac transplant waiting list\n* More than mild right ventricular dysfunction\n* Valve disease\n\n  * Mitral regurgitation \\> moderate\n  * Mitral stenosis \\> mild\n  * Tricuspid regurgitation \\> moderate\n  * Aortic regurgitation \\> moderate\n  * Aortic stenosis \\> moderate\n* Body mass index (BMI) ≥45\n* Myocardial infarction and\u002For any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization\n* Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months\n* Cardiac resynchronization therapy implanted within the past 12 months\n* Renal insufficiency as determined by serum creatinine (sCr) level \\>2.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\\u003C25 ml\u002Fmin\u002F1.73 m2\n* Performance of the 6-minute walk test with a distance \\\u003C100 m or \\>450 m\n* Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure\n* Presence of one or more of the following resting hemodynamic findings:\n\n  1. Mean pulmonary capillary wedge pressure (PCWP) \\>35 mmHg\n  2. Mean right atrial pressure (RAP) \\>15 mmHg\n  3. Mean PCWP-mean RAP gradient \\\u003C 5 mmHg\n  4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)\n  5. Cardiac index \\\u003C1.8 L\u002Fmin\u002Fm2","ALL","18 Years",{"count":309,"type":310},90,"ESTIMATED","INTERVENTIONAL",[47],"The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.",[315],"Heart Failure","2026-09-29",{"date":318,"type":319},"2026-10-02","ACTUAL",{"date":321,"type":319},"2018-07-31",{"date":323,"type":310},"2032-04",{"name":5,"class":6},19]