[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480673":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":52,"centralContacts":56,"locations":63,"responsibleParty":81,"collaborators":30,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":30,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":66,"whyStopped":30,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Right atrial GP ablation in addition to pulmonary vein isolation",[13,14,15,16,17],"Procedure: Right Atrial ganglionated plexus ablation","Diagnostic Test: Holter Monitor","Procedure: Pulmonary vein isolation","Diagnostic Test: Personal ECG recordings","Other: Quality of life questionnaire",{"label":19,"type":20,"description":21,"interventionNames":22},"Control","ACTIVE_COMPARATOR","PVI alone with no GP mapping or ablation",[14,15,23,16,17],"Procedure: Right cavo-tricuspid and left roof linear ablation",[25,31,36,40,44,48],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Right Atrial ganglionated plexus ablation","A 3D electroanatomic map of the right atrium will be made. During sinus rhythm, the ablation catheter will be positioned at a spot to test with HFS. The right atrium will be paced at a fixed rate, for up to four beats to ensure that there is no ventricular capture then a short burst of HFS will be synchronized to each paced stimulus for up to 15 trains. This will be performed using a custom-built GP stimulator that has been validated for reproducibility against Grass Stimulator (AstroMed).\n\nAll Sites will be marked on the 3D map and the positive sites will be ablated at the end of the mapping. If the patient converts to AF, then DC cardioversion will be performed. If mapping in sinus rhythm is not feasible, HFS will be performed continuously for several seconds to identify atrioventricular dissociating GPs (AVD-GPs).\n\nEvery ablated GP site will be re-tested with HFS at the end of the procedure until they are all rendered non-functional.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DIAGNOSTIC_TEST","Holter Monitor","48 hour Holter monitors will be performed post procedure to monitor for recurrence of AF.\n\nThese will be performed at 3, 6, 9, 12 months",[19,9],{"type":26,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Pulmonary vein isolation","Transseptal puncture for access into the left atrium will be guided by TOE and fluoroscopy.\n\nACT will be maintained at 300s with heparin. A 3D electroanatomic map of the left atrium will be created and all PVs will be identified. Touch-up radiofrequency ablation will be performed at electrical gaps around the reconnected PVs until complete PVI is achieved.",[19,9],{"type":26,"name":41,"description":42,"armGroupLabels":43,"otherNames":30},"Right cavo-tricuspid and left roof linear ablation","CONTROL ARM (Redo-PVI) only: If all Pulmonary veins are isolated at the start of the procedure, the operator will be allowed to perform a right cavo-tricuspid and left roof linear ablation.",[19],{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Personal ECG recordings","All patients will be provided with an AliveCor KardiaMobile-6L ECG recorder. The device will continue to be used within its CE-marked and NICE-approved purpose. Patients will be asked to take a daily recording from this, once the blanking period is over, in addition to taking a recording if symptomatic. Patients will submit this to the connected care team at Hammersmith Hospital via a secure NHS.net email address, who will assess the recordings both for the study and clinical purposes.",[19,9],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"Quality of life questionnaire","A Quality of life questionnaire will be performed at baseline, 6 and 12 months to assess the effect of the procedures on patients quality of life.",[19,9],[53],{"name":54,"affiliation":5,"role":55},"Prapa Kanagaratnam, MBBChir, PhD","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"Jamie Kay, MBBS BMedSci","CONTACT","02033131000","via switch","jamie.kay@imperial.ac.uk",[64],{"facility":65,"status":66,"city":67,"state":30,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Hammersmith Hospital","RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":72,"coordinates":73},"Point",[74,75],-0.12574,51.50853,{"lat":75,"lon":74},[78],{"name":79,"role":59,"phone":30,"phoneExt":30,"email":80},"Jamie Kay, MBBS, BMedSci","jamie.kay@nhs.net",{"type":82,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100480673","the-role-of-right-atrial-ectopy-triggering-ganglionated-plexuses-in-af-100480673",false,"NCT05539040","The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF","Understanding the Role of Right Atrial Ectopy-triggering Ganglionated Plexuses in Atrial Fibrillation","RGanglia-AF","Inclusion Criteria:\n\n* Males or females from 18 to 85yrs old\n* Symptomatic paroxysmal atrial fibrillation\n* Suitable candidate for catheter ablation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Contraindication to catheter ablation\n* Contraindication for general anaesthetic\n* Presence of a left ventricular thrombus\n* Valvular disease that is grade moderate or greater\n* Any form of cardiomyopathy\n* Severe cerebrovascular disease\n* Active gastrointestinal bleeding\n* Serum Creatinine \\>200umol\u002FL\u002F on dialysis\u002F at risk of dialysis\n* Active infection or fever\n* Life expectancy shorter than the duration of the trial\n* Allergy to contrast\n* Moderate to severe heart failure and\u002For NYHA Class III-IV\n* Bleeding or clotting disorders or inability to receive heparin\n* Uncontrolled diabetes (HbA1c ≥73mmol\u002Fmol or HbA1c ≤64mmol\u002Fmol and Fasting Blood Glucose ≥9.2mmol\u002FL)\n* Malignancy needing therapy\n* Pregnancy or women of childbearing potential not using a highly effective method of contraception\n* Unable to give informed consent","ALL","18 Years","85 Years",{"count":95,"type":96},116,"ESTIMATED","INTERVENTIONAL",[99],"NA","Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes.\n\nThe best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people.\n\nThe study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs).\n\nThe study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again",[102,103],"Cardiac Arrhythmia","Atrial Fibrillation",[103,105,106,107,108,109,110,111,112],"Ganglionated plexus","Arrhythmia","Cardiology","Right atrium","Ectopy","Electrophysiology","GP","AF","2023-09-26",{"date":115,"type":116},"2023-09-28","ACTUAL",{"date":118,"type":116},"2023-02-21",{"date":120,"type":96},"2027-12-02",{"name":5,"class":6},1]