[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625596":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":68,"collaborators":72,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":44,"enrollmentInfo":100,"targetDuration":44,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":119,"whyStopped":44,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Catheter Ablation Strategy","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo catheter ablation for atrial fibrillation, with pulmonary vein isolation (PVI) prioritized as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology). Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Additional medical therapy may be used as clinically indicated according to guideline-based care.",[13,14,15],"Procedure: Catheter Ablation for Atrial Fibrillation","Drug: Optimized Medical Therapy for Atrial Fibrillation","Device: Implantable Loop Recorder (ILR)",{"label":17,"type":10,"description":18,"interventionNames":19},"Optimized Medical Therapy (Rate\u002FRhythm control) ± AV Node Ablation + Pacing + ILR","Participants randomized to this arm will receive optimized guideline-directed medical therapy for atrial fibrillation without AF catheter ablation. Treatment may include rate control and\u002For rhythm control (including antiarrhythmic drugs and\u002For cardioversion when clinically appropriate). AV node ablation with pacemaker implantation is permitted when clinically indicated according to routine care. Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up.",[14,20],"Procedure: AV Node Ablation With Pacemaker implantation",[22,30,39,45],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Catheter Ablation for Atrial Fibrillation","Catheter ablation for symptomatic atrial fibrillation with pulmonary vein isolation (PVI) prioritized as the primary lesion set. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology), performed under routine standards of care at experienced centres.",[9],[28,29],"catheter ablation","pulmonary vein isolation",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Optimized Medical Therapy for Atrial Fibrillation","Guideline-directed rate and\u002For rhythm control tailored to the participant's clinical condition, including rate-control medications and\u002For antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy.",[9,17],[36,37,38],"Guideline-directed medical therapy","Rate control","Rhythm control",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DEVICE","Implantable Loop Recorder (ILR)","Subcutaneous implantable loop recorder used for continuous rhythm monitoring and quantification of atrial fibrillation burden throughout follow-up. Implanted in all participants according to protocol-defined workflow.",[9],null,{"type":23,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"AV Node Ablation With Pacemaker implantation","AV node ablation with permanent pacing may be performed when clinically indicated according to routine care, as part of the optimized medical therapy strategy.",[17],[50],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},"Emmanouil Charitakis, MD, PhD","CONTACT","0046767877506","emmanouil.charitakis@regionstockholm.se",[56],{"facility":5,"status":44,"city":57,"state":44,"zip":44,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Stockholm","Sweden","SE",{"type":61,"coordinates":62},"Point",[63,64],18.06871,59.32938,{"lat":64,"lon":63},[67],{"name":51,"role":52,"phone":53,"phoneExt":44,"email":54},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Emmanouil Charitakis","MD, PhD",[73,75,77,79,82,84,86,88],{"name":74,"class":6},"University Hospital, Linkoeping",{"name":76,"class":6},"Sahlgrenska University Hospital",{"name":78,"class":6},"University Hospital, Umeå",{"name":80,"class":81},"Dept of Cardiology, Örebro University Hospital, Sweden","UNKNOWN",{"name":83,"class":6},"Lund University Hospital",{"name":85,"class":6},"Onassis Cardiac Surgery Centre",{"name":87,"class":6},"Uppsala University Hospital",{"name":89,"class":6},"University Hospital, Gentofte, Copenhagen","100625596","catheter-ablation-vs-conservative-care-in-elderly-patients-with-atrial-fibrillation-100625596",false,"NCT07424690","Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation","Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study","ACE-AF","Inclusion Criteria:\n\n1. Age ≥78 years.\n2. ECG-documented atrial fibrillation.\n3. AF type: paroxysmal, persistent, or longstanding persistent AF.\n4. Suitable candidate for catheter ablation according to ESC guidelines.\n5. Charlson's comorbidity index ≤7.\n\nExclusion Criteria:\n\n1. Left atrial (LA) dimension \\>55 mm, based on echocardiography within the previous year.\n2. Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.\n3. Severe valvular heart disease (per ESC definitions) or congenital heart disease.\n4. Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.\n5. Contraindication to oral anticoagulation.\n6. AF due to a reversible cause.\n7. Medical condition likely to limit survival to \\\u003C12 months.\n8. Unable or unwilling to provide informed consent.\n9. History of non-compliance with medical therapy.\n10. BMI \\\u003C18 or \\>37 kg\u002Fm².","ALL","78 Years",{"count":101,"type":102},282,"ESTIMATED","INTERVENTIONAL",[105],"NA","ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.\n\nThe study compares two established treatment strategies:\n\n1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and\n2. Optimized medical therapy without AF ablation (medications for rate and\u002For rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).\n\nParticipants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.\n\nThe study has two co-primary outcomes assessed over 24 months:\n\n1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and\n2. patient-reported health-related quality of life (HRQoL), measured by the SF-36 \"General Health\" domain.\n\nACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.",[108,109,110],"Atrial Fibrillation (AF)","Atrial Fibrillation Ablation","Elderly",[112,28,113,114,115,116,117,118],"atrial fibrillation","rhtyhm control","rate control","implantable loop recorder","elderly","Health-related quality of life","Randomized controlled study","NOT_YET_RECRUITING","2026-02-14",{"date":122,"type":123},"2026-02-20","ACTUAL",{"date":125,"type":102},"2026-05-20",{"date":127,"type":102},"2034-09-01",{"name":5,"class":6},1]