[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523481":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":53,"locations":62,"responsibleParty":80,"collaborators":34,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":34,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":34,"overallStatus":65,"whyStopped":34,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Barts & The London NHS Trust","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: DCCV + PVI","ACTIVE_COMPARATOR","An implantable loop recorder will be inserted in the pre pectoral area with local anaesthetic at least one week before the randomisation.\n\nTwo femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for ablation and for phrenic nerve pacing during the procedure.\n\nDC cardioversion (DCCV) plus Pulmonary Vein Isolation - At the end of pulmonary vein isolation, DCCV is performed (if the patient is still in AF).",[13,14,15,16],"Procedure: Pulmonary vein isolation","Procedure: DC Cardioversion","Device: Implantable loop recorder","Procedure: Femoral sheath insertion",{"label":18,"type":19,"description":20,"interventionNames":21},"DC cardioversion (DCCV) + Sham procedure","SHAM_COMPARATOR","An implantable loop recorder will be inserted in the pre-pectoral area with local anaesthetic at least one week before the randomisation.\n\nTwo femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for intermittent phrenic nerve pacing during the procedure.\n\nDC Cardioversion and Sham procedure will be performed after randomisation. Intermittent phrenic nerve pacing will be employed for the sham group through the femoral venous sheath using a quadripolar catheter.",[14,15,16],[23,30,35,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Pulmonary vein isolation","The catheter ablation (with a CE \\[Conformité Européenne\\] marked device) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential ablation around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.",[9],[29],"Catheter ablation",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DC Cardioversion","DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.",[18,9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Implantable loop recorder","The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at least a week before the randomisation. The device will provide a continuous recording of the heart rhythm and rate, and will be able to download duration of AF episodes via a home monitoring system to establish the primary endpoint of the study .",[18,9],[41],"Reveal LINQ",{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":34},"Femoral sheath insertion","Two femoral sheaths (7Fr) will be inserted using ultrasound guidance under local anaesthetic.",[18,9],[47,50],{"name":48,"affiliation":5,"role":49},"Richard Schilling, FRCP MD","STUDY_CHAIR",{"name":51,"affiliation":5,"role":52},"Malcolm Finlay","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":34,"email":58},"Malcolm Finlay, FRCP PhD","CONTACT","02037658635","malcolm.finlay1@nhs.net",{"name":60,"role":56,"phone":57,"phoneExt":34,"email":61},"Vijayabharathy Kanthasamy, MRCP","vijayabharathy.kanthasamy@nhs.net",[63],{"facility":64,"status":65,"city":66,"state":34,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Barts Heart Centre","RECRUITING","London","EC1A 7BE","United Kingdom","UK",{"type":71,"coordinates":72},"Point",[73,74],-0.12574,51.50853,{"lat":74,"lon":73},[77,78],{"name":51,"role":56,"phone":57,"phoneExt":34,"email":58},{"name":79,"role":56,"phone":57,"phoneExt":34,"email":61},"Vijayabharathy Kanthasamy",{"type":81,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100523481","investigation-of-cardioversion-versus-therapeutic-ablation-for-persistent-af-orbica-af-100523481",false,"NCT06096246","Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)","Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)","ORBICA-AF","Inclusion Criteria:\n\n* Ability to give informed consent\n* Age 18-85 years\n* Persistent AF (atrial fibrillation lasting \\> 7days) of total continuous duration \\\u003C2 years as documented in medical notes.\n* Patients being considered for cardioversion.\n\nExclusion Criteria:\n\n* Creatinine clearance (eGFR) \\\u003C 30mls\u002Fmin\n* Contraindication or unable to take anticoagulation\n* Uncontrolled hypertension\n* Contraindication for catheter ablation\n* BMI \\> 40\n* Patients in Persistent AF who have had more than one previous cardioversion.\n* Established diagnosis of Hypertrophic cardiomyopathy","ALL","18 Years","85 Years",{"count":94,"type":95},208,"ESTIMATED","INTERVENTIONAL",[98],"NA","The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with catheter ablation for persistent atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure.",[101,102,103],"Persistent Atrial Fibrillation","Cardiac Arrhythmia","Catheter Ablation","2025-09-01",{"date":106,"type":107},"2025-09-03","ACTUAL",{"date":109,"type":107},"2024-07-26",{"date":111,"type":95},"2027-12-05",{"name":5,"class":6},1]