[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559124":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":157,"collaborators":160,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":172,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":17,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":40,"whyStopped":17,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Catheter Ablation","Patients randomized to the intervention will undergo early catheter ablation with pulmonary vein isolation as treatment for AF. Catheter ablation should be conducted within 6 weeks of randomization.",[12],"Procedure: Catheter ablation",{"label":14,"type":15,"description":16,"interventionNames":17},"Standard treatment","NO_INTERVENTION","Patients randomized to standard treatment will receive standard guideline directed treatment for AF and HF. Treatment will be initiated at the baseline visit and further clinical follow-up will be conducted at the patients local hospital. Patient will be treated with either rhythm (excluding catheter ablation) or rate control. The choice of treatment strategy will be at the discretion of the treating physician according to current guideline recommendations. If rate control is chosen, patients should have a resting heart rate \\\u003C 110 beats per minutes. Rate control can be obtained by medical treatment with digoxin, beta-blockers and if needed amiodarone, in combination or as single treatment. Rhythm control will be conducted through cardioversion and\u002For medical treatment with amiodarone. Catheter ablation will not be part of the treatment choices in the standard treatment arm.",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"PROCEDURE","Catheter ablation","Catheter ablation with pulmonary vein isolation will be the study intervention. Patients randomized to the intervention arm will undergo catheter ablation within six weeks of randomization. In the waiting-time for ablation, patients will receive standard treatment for AF and HF, as per current guideline recommendations. Catheter ablation will be performed at one of six high-volume ablation centers in Denmark. Mode of catheter ablation will be at the discretion of the operator. Radiofrequency ablation, cryo-balloon ablation and pulsed-field ablation will be utilized. The treating physician should ensure successful pulmonary vein isolation after ablation with either post-procedural mapping or pacing, as per current standards. Only pulmonary vein isolation will be performed during the ablation procedure.",[9],[25],{"name":26,"affiliation":27,"role":28},"Sam Riahi, MD, PhD","Department of Cardiology, Aalborg Univeristy Hospital","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":17,"email":34},"Anne-Christine Ruwald, MD, PhD","CONTACT","+45 40177181","anne.christine.huth.ruwald@regionh.dk",{"name":26,"role":32,"phone":17,"phoneExt":17,"email":36},"sar@rn.dk",[38,60,83,104,122,143],{"facility":39,"status":40,"city":41,"state":17,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Aalborg University Hospital, Department of Cardiology","RECRUITING","Aalborg","9000","Denmark","DK",{"type":46,"coordinates":47},"Point",[48,49],9.9187,57.048,{"lat":49,"lon":48},[52,53,56,57],{"name":26,"role":32,"phone":17,"phoneExt":17,"email":36},{"name":54,"role":32,"phone":17,"phoneExt":17,"email":55},"Ditte Hansen","ditte.hansen@rn.dk",{"name":26,"role":28,"phone":17,"phoneExt":17,"email":17},{"name":58,"role":59,"phone":17,"phoneExt":17,"email":17},"Søren Vraa, MD, PhD","SUB_INVESTIGATOR",{"facility":61,"status":62,"city":63,"state":17,"zip":64,"country":43,"countryCode":44,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Aarhus University Hospital","NOT_YET_RECRUITING","Aarhus","8200",{"type":46,"coordinates":66},[67,68],10.21076,56.15674,{"lat":68,"lon":67},[71,74,77,78,80,81],{"name":72,"role":32,"phone":17,"phoneExt":17,"email":73},"Henrik Vase, MD, PhD","henvas@rm.dk",{"name":75,"role":32,"phone":17,"phoneExt":17,"email":76},"Mads Brix Kronborg, MD, PhD","madskron@rm.dk",{"name":72,"role":28,"phone":17,"phoneExt":17,"email":17},{"name":79,"role":59,"phone":17,"phoneExt":17,"email":17},"Henrik Wiggers, MD, PhD",{"name":75,"role":59,"phone":17,"phoneExt":17,"email":17},{"name":82,"role":59,"phone":17,"phoneExt":17,"email":17},"Jens Cosedis Nielsen, MD, DMSc",{"facility":84,"status":40,"city":85,"state":17,"zip":86,"country":43,"countryCode":44,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Department of Cardiology, Rigshospitalet","Copenhagen","2100",{"type":46,"coordinates":88},[89,90],12.56553,55.67594,{"lat":90,"lon":89},[93,95,98,99,100,102],{"name":31,"role":32,"phone":94,"phoneExt":17,"email":34},"+4540177181",{"name":96,"role":32,"phone":17,"phoneExt":17,"email":97},"Lars Køber, MD, DMSc","lars.kober@regionh.dk",{"name":96,"role":28,"phone":17,"phoneExt":17,"email":17},{"name":31,"role":59,"phone":17,"phoneExt":17,"email":17},{"name":101,"role":59,"phone":17,"phoneExt":17,"email":17},"Christian Jøns, MD, PhD",{"name":103,"role":59,"phone":17,"phoneExt":17,"email":17},"Jesper Hastrup Svendsen, MD, DMSc",{"facility":105,"status":40,"city":106,"state":17,"zip":107,"country":43,"countryCode":44,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Department of Cardiology, Herlev-Gentofte University Hospital","Hellerup","2900",{"type":46,"coordinates":109},[110,111],12.57093,55.73204,{"lat":111,"lon":110},[114,117,120,121],{"name":115,"role":32,"phone":17,"phoneExt":17,"email":116},"Morten Schou, MD, PhD","morten.schou.04@regionh.dk",{"name":118,"role":32,"phone":17,"phoneExt":17,"email":119},"Morten Lock Hansen, MD, PhD","morten.lock.hansen@regionh.dk",{"name":115,"role":28,"phone":17,"phoneExt":17,"email":17},{"name":118,"role":59,"phone":17,"phoneExt":17,"email":17},{"facility":123,"status":62,"city":124,"state":17,"zip":125,"country":43,"countryCode":44,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Department of Cardiology, Odense University Hospital","Odense","5000",{"type":46,"coordinates":127},[128,129],10.38831,55.39594,{"lat":129,"lon":128},[132,135,138,139,141],{"name":133,"role":32,"phone":17,"phoneExt":17,"email":134},"Jens Brock Johansen, MD, PhD","brock@dadlnet.dk",{"name":136,"role":32,"phone":17,"phoneExt":17,"email":137},"Lisbeth Anthonsen, MD, PhD","lisbeth.antonsen@rsyd.dk",{"name":133,"role":28,"phone":17,"phoneExt":17,"email":17},{"name":140,"role":59,"phone":17,"phoneExt":17,"email":17},"Lisbeth Anthonsen, Md, PhD",{"name":142,"role":59,"phone":17,"phoneExt":17,"email":17},"Mikael Kjær Poulsen, MD, PhD",{"facility":144,"status":62,"city":145,"state":17,"zip":146,"country":43,"countryCode":44,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Department of Cardiology, Zealand University Hospital","Roskilde","4000",{"type":46,"coordinates":148},[149,150],12.08035,55.64152,{"lat":150,"lon":149},[153,156],{"name":154,"role":32,"phone":17,"phoneExt":17,"email":155},"Uffe Gang, MD, PhD","ujg@regionsjaelland.dk",{"name":154,"role":28,"phone":17,"phoneExt":17,"email":17},{"type":28,"investigatorFullName":158,"investigatorTitle":159,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Sam Riahi","Professor",[161,163,165,166,168],{"name":162,"class":6},"Rigshospitalet, Denmark",{"name":164,"class":6},"Odense University Hospital",{"name":61,"class":6},{"name":167,"class":6},"Zealand University Hospital",{"name":169,"class":6},"Herlev and Gentofte Hospital","100559124","danish-evaluation-of-early-catheter-ablation-for-atrial-fibrillation-in-patients-with-heart-failure-100559124",false,"NCT06560047","Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure","Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial","DanAblate-HF","Inclusion Criteria:\n\n1. HF patients with AF within the past 12 months\n\n   HF is defined as all of the below (all must apply)\n   * Clinically assessed Heart Failure with Reduced Ejection Fraction (HFrEF)\n   * An indication for initiation or ongoing guideline directed medical therapy for HFrEF, according to current Heart Failure guidelines\n   * LVEF \\\u003C 50% at any point during the past 12 months\n\n   AF is defined as one or more of the following:\n\n   A. Symptomatic AF, documented by ECG, Holter of CIED\n\n   B. Asymptomatic AF with one or more of the following:\n   * Clinical indication for rhythm or rate control (documented by ECG, telemetry, Holter, CIED)\n   * ≥2 ECG detected AF episodes within 3 months (on separate dates)\n   * Holter detected AF with a continuous duration of more than 6 hours\n   * CIED detected AF with continuous duration \\>24 hours\n2. 18 years ≤ Age \\\u003C80 years\n3. Optimal medical therapy for HFrEF or planned\u002Fcurrent uptitration in guideline directed medical therapy for HFrEF\n4. Treatment with anticoagulation for stroke prevention, initiated according to guidelines for treatment of AF\n\nExclusion Criteria:\n\n1. Life-expectancy \\\u003C 1 year\n2. BMI \\> 40\n3. Contraindications or unacceptable side effects to rate limiting drugs AND amiodarone\n4. LA size (indexed for BSA) \\> 60 ml\u002Fm2 (volume) on echo within the last year\n5. Documented persistent\u002Fpermanent AF \\> 1 year\n6. Previous AF ablation\u002Fsurgery\n7. Reversible causes of AF (including, but not limited to, infection within 14 days, untreated thyroid disease, surgery)\n8. Severe valvular disease\n9. Acute myocardial infarction, cardiothoracic surgery or stroke within the past 3 months\n10. Planned cardiothoracic surgery\n11. Listed for heart transplant\n12. Contraindications for anticoagulation therapy or catheter ablation\n13. Severe kidney disease (CKD≥5)\n14. Pregnancy\n15. Patient unwilling to try medical therapy for AF\n16. Patient unwilling\u002Funable to give informed consent for study participation","ALL","18 Years","80 Years",{"count":182,"type":183},1616,"ESTIMATED","INTERVENTIONAL",[186],"NA","The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.",[189,190],"Atrial Fibrillation","Heart Failure",[192,193,21,194,195],"Heart failure","Atrial fibrillation","Treatment","Outcome","2024-08-29",{"date":198,"type":199},"2024-08-30","ACTUAL",{"date":201,"type":199},"2024-08-28",{"date":203,"type":183},"2039-08-31",{"name":5,"class":6},6]