[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478306":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":46,"locations":51,"responsibleParty":68,"collaborators":71,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Catheter Ablation","ACTIVE_COMPARATOR","Symptomatic HFmrEF or HFpEF patients with AF that meet I\u002FE criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Patients assigned to rhythm control group will be treated with catheter ablation as first line therapy to restore and maintain sinus rhythm, additionally to the therapeutic recommendations of the current ESC guidelines for the management of atrial fibrillation (AF) and the current ESC Heart Failure (HF) guidelines.",[13],"Device: CE-marked Catheter Ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Medical Care","NO_INTERVENTION","Symptomatic HFmrEF or HFpEF patients with AF that meet I\u002FE criteria will be randomized 1:1 to receive either CA or usual medical care without the aim of CA. Subjects randomized to usual care will be treated according to current ESC guidelines for the management of AF and current ESC HF guidelines. Usual care of AF in the context of CABA-HFPEF consists of an initial treatment limited to rate control in addition to adequate antithrombotic therapy, typically oral anticoagulation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","CE-marked Catheter Ablation","Once patients have been randomized to the catheter ablation (CA) group, the ablation procedure must be performed within 4 weeks. CA will initially aim at pulmonary vein isolation.",[9],[26,30,34,37,40,43],{"name":27,"affiliation":28,"role":29},"Abdul Parwani, Dr.","Head of Electrophysiology; Charité University Medicine Berlin, CVK","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":33},"Paulus Kirchhof, Prof. Dr.","Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf","STUDY_CHAIR",{"name":35,"affiliation":36,"role":33},"Stefan Kääb, Prof. Dr.","Department of Cardiology, Ludwig-Maximilians-University Hospital Munich",{"name":38,"affiliation":39,"role":33},"Tim Friede, Prof. Dr.","Departement of Medical Statistics, University Medical Center Göttingen",{"name":41,"affiliation":42,"role":33},"Roland Tilz, Prof. Dr.","Head of Electrophysiology Department, University Hospital Lübeck",{"name":44,"affiliation":45,"role":33},"Burkert Pieske, Prof. Dr.","Independent",[47],{"name":27,"role":48,"phone":49,"phoneExt":18,"email":50},"CONTACT","+4930450565383","caba_hfpef@charite.de",[52],{"facility":53,"status":54,"city":55,"state":18,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Charité University Medicine Berlin, Campus Virchow Klinikum","RECRUITING","Berlin","13353","Germany","DE",{"type":60,"coordinates":61},"Point",[62,63],13.41053,52.52437,{"lat":63,"lon":62},[66],{"name":27,"role":48,"phone":67,"phoneExt":18,"email":50},"004930450565383",{"type":29,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Abdul Parwani","Head of Electrophysiology",[72,74,77],{"name":73,"class":6},"Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)",{"name":75,"class":76},"Kompetenznetz Vorhofflimmern e.V. (AFNET)","UNKNOWN",{"name":78,"class":79},"Boston Scientific Corporation","INDUSTRY","100478306","phase-4-catheter-based-ablation-of-atrial-fibrillation-compared-to-conventional-treatment-in-patients-with-heart-failure-with-preserved-ejection-fraction-100478306",false,"NCT05508256","CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction","CABA-HFPEF","INCLUSION CRITERIA:\n\n1. Age ≥18 years\n2. Signed written informed consent\n3. Clinical evidence of symptomatic heart failure (NYHA Class II-III)\n4. Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)\n5. Left ventricular ejection fraction (LVEF) 40-49%\n\n   OR\n\n   LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local measurement made during the screening epoch):\n\n   A. LA enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml\u002Fm2\n\n   B. Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1 cm or relative wall thickness \\>0.42)\n6. Patients with at least 1 of the following:\n\nA. HF hospitalization (defined as HF listed as the major reason for hospitalization) within 6 months prior to screening visit and NT-proBNP \\>200 pg\u002Fml for patients in sinus rhythm (SR) or \\>600 pg\u002Fml for patients in AF at the time of blood sampling\n\nB. NT-proBNP \\>300 pg\u002Fml for patients in SR or \\>900 pg\u002Fml for patients in AF on screening ECG\n\nEXCLUSION CRITERIA:\n\n1. Patient is unable or unwilling to provide infomed consent\n2. Patient is not suitable for rhythm control of AF\n3. Previous left atrial CA or surgical therapy of AF\n4. Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)\n5. Valvular heart disease needing interventional or surgical treatment within 3 months\n6. Heart surgery planned within 3 months\n7. Prior heart transplant or listed for heart transplant or cardiac assist device implantation\n8. Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)\n9. Patient has absolute contra-indication to oral anticoagulation\n10. Any disease that limits life expectancy to less than 1 year\n11. Active systemic infection (after successful treatment of infection, patients may be enrolled)\n12. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \\\u003C 1%)\n13. Patient is included in another clinical trial\n14. Inability to comply with the study procedures","ALL","18 Years",{"count":90,"type":91},1548,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).",[97,98,99],"Atrial Fibrillation","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction",[101,102,103,104],"atrial fibrillation","heart failure","catheter ablation","medial therapy","2023-03-03",{"date":107,"type":108},"2023-03-06","ACTUAL",{"date":110,"type":91},"2023-03",{"date":112,"type":91},"2027-07",{"name":5,"class":6},1]