[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576328":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":38,"overallOfficials":49,"centralContacts":54,"locations":60,"responsibleParty":115,"collaborators":21,"id":117,"slug":21,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":21,"enrollmentInfo":126,"targetDuration":21,"studyType":129,"phases":21,"briefSummary":130,"conditions":131,"keywords":21,"overallStatus":134,"whyStopped":21,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Functional neurologic outcome - Modified Rankin Scale","Modified Rankin Scale is widely used to assess neurologic dysfunction in a broad range of neurologic and neurosurgical conditions. It is a 6-level ordinal outcome scale (0-5) used to assess the functional status of patients, encoding the range from no symptoms or functional impairment (mRS = 0) to severe disability requiring constant nursing care (mRS = 5)","1 Month, 3 Months, 6 Months, 9 Months and 12 Months",{"measure":14,"description":15,"timeFrame":16},"Recurrent Stroke","A recurrent stroke is when a person has another stroke following their first stroke. Experiencing one can have a major impact on a person's quality of life.","12 Months",[18],{"measure":19,"description":20,"timeFrame":12},"Functional neurologic outcome - Quality of Life","The AF Effect on Quality-of-Life questionnaire - AFEQT for short - is a reliable and responsive measure of quality of life, developed especially for atrial fibrillation. Overall or subscale scores range from 0-100.\n\nA score of 0 corresponds to complete disability (or responding \"extremely\" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding \"not at all\" limited, difficult or bothersome to all questions answered).",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_CONTROL","PROSPECTIVE","A prospective, non-blinded, multi-center study to assess the impact of early CA in patients with a new diagnosis of AF at the time of stroke. At least 100 patients who meet the inclusion and exclusion criteria will be randomized 1:1 to receive early CA or SOC (Standard of Care). The primary outcome will be the functional neurologic outcomes, including mRS (modified Rankin Scale) and QOL(Quality of Life), recurrence, major bleeding, and mortality after stroke for each group. Secondary outcomes will be changes in cognitive assessment, success of rhythm control, recurrent hospitalizations, and cumulative cardiovascular outcomes. Participants will be followed at 3, 6, 9, and 12 months following the discharge date to measure these outcomes, and the study will enroll for one year. The primary endpoints will be functional recovery and enrollment.","Patients with atrial fibrillation (AF) and recent stroke.",[28,33],{"label":29,"type":21,"description":30,"interventionNames":31},"Routine Medication Therapy","Will receive SOC following AF diagnosis in the setting of stroke. This includes rate control with a combination of atrioventricular nodal blockers (AVNB) (Metoprolol, Diltiazem, etc.) and initiation of oral anticoagulation (OAC) (either Eliquis, Xarelto, or Warfarin) within 1-14 days per recommendations of the Stroke Team. If arrhythmia remains uncontrolled, patients will be started on an anti-arrhythmic drugs (AAD) (either Flecainide, Dofetilide, Propafenone, Sotalol, Amiodarone, etc.) per Electrophysiology. Doses of medications will be determined by the managing physician. If a patient was\u002Fis started or on triple therapy, this will be converted to appropriate anti-platelet and OAC. Patients will continue this management if AF is controlled. Patients can still undergo CA for rhythm control at the discretion of the managing Electrophysiologist.",[32],"Drug: Market-approved AVNB, OAC and AAD",{"label":34,"type":21,"description":35,"interventionNames":36},"Atrial Fibrillation Ablation","When randomized to this group, patients will subsequently receive earlier rhythm control. They will undergo SOC following AF diagnosis in the setting of stroke as above. This can include AVNB and OAC. However, these patients will also be assigned to start AAD before discharge from the hospital. They will subsequently undergo CA 30-120 days from discharge from the hospital. The lesions to be ablated will be determined by electrophysiology study (EPS) with electroanatomic mapping and subsequently selected by the operator to optimize each patient situation.",[37],"Device: Catheter Ablation",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":21},"DEVICE","Catheter Ablation","Catheter Ablation is commonly performed with radiofrequency or cryotherapy to maintain a rhythm control strategy if patients can no longer tolerate their symptoms or are no longer controlled on AVNB or AAD. The procedure leads to significant symptom improvement even though there may be insignificant AF recurrence at one year. At Kansas City Heart Rhythm Institute, CA may be performed with radiofrequency ablation (Tactiflex Ablation Catheter, Abbott Cardiovascular, Minneapolis, MN) or pulsed field ablation (PulseSelectTM, Abbott Cardiovascular or FaraWaveTM, Boston Scientific, Marlborough, MA), performed with EnsiteX (Abbott Cardiovascular) or Carto3 (Biosense Webster, Irvine, CA) mapping software.",[34],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":21},"DRUG","Market-approved AVNB, OAC and AAD","Used per protocol for the duration of the trial.",[29],[50],{"name":51,"affiliation":52,"role":53},"Dhanunjaya Lakkireddy, MD","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":21,"email":59},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[61,74,80,86,96,101,110],{"facility":62,"status":21,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":21},"Menorah Medical Center","Overland Park","Kansas","66209","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-94.67079,38.98223,{"lat":72,"lon":71},{"facility":75,"status":21,"city":63,"state":64,"zip":76,"country":66,"countryCode":67,"cosmosGeoPoint":77,"geoPoint":79,"contacts":21},"Kansas City Heart Rhythm Institute - Roe Clinic","66211",{"type":69,"coordinates":78},[71,72],{"lat":72,"lon":71},{"facility":81,"status":21,"city":63,"state":64,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":85,"contacts":21},"Overland Park Regional Medical Center","66215",{"type":69,"coordinates":84},[71,72],{"lat":72,"lon":71},{"facility":87,"status":21,"city":88,"state":89,"zip":90,"country":66,"countryCode":67,"cosmosGeoPoint":91,"geoPoint":95,"contacts":21},"Centerpoint Medical Center Clinic","Independence","Missouri","64057",{"type":69,"coordinates":92},[93,94],-94.41551,39.09112,{"lat":94,"lon":93},{"facility":97,"status":21,"city":88,"state":89,"zip":90,"country":66,"countryCode":67,"cosmosGeoPoint":98,"geoPoint":100,"contacts":21},"Centerpoint Medical Center",{"type":69,"coordinates":99},[93,94],{"lat":94,"lon":93},{"facility":102,"status":21,"city":103,"state":89,"zip":104,"country":66,"countryCode":67,"cosmosGeoPoint":105,"geoPoint":109,"contacts":21},"Research Medical Center Clinic","Kansas City","64032",{"type":69,"coordinates":106},[107,108],-94.57857,39.09973,{"lat":108,"lon":107},{"facility":111,"status":21,"city":103,"state":89,"zip":104,"country":66,"countryCode":67,"cosmosGeoPoint":112,"geoPoint":114,"contacts":21},"Research Medical Center",{"type":69,"coordinates":113},[107,108],{"lat":108,"lon":107},{"type":116,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100576328",false,"NCT06783868","Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control","Randomized Control Study to Assess the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control vs Routine Medication Therapy in Patients With Recent Stroke: SAVE STROKE Phase II Study","SAVE STROKE II","Inclusion Criteria:\n\n* Ages \\>18 and able to provide consent.\n* Presenting with an acute stroke and new-onset AF\n* Modified RANKIN score (mRS) \\\u003C 6\n* Must be able to undergo some form of cardiac monitoring \\[implantable loop recorder (ILR), electrocardiogram (ECG), Holter monitor\\] to quantify AF burden\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age\n* Unable to provide consent, including mRS = 6.\n* Not able to read and write at an 8th-grade level \\[to complete AFEQT and EQ-5D surveys\\]\n* Positive B-hCG\n* Will not follow up with our practice\u002Fclinic afterward.\n* Cannot tolerate OAC or AAD for any reason.\n* Cannot undergo CA for any reason.","ALL","18 Years",{"count":127,"type":128},100,"ESTIMATED","OBSERVATIONAL","A prospective, non-blinded, multi-center study to assess the impact of early Catheter Ablation (CA) in patients with a new diagnosis of Atrial Fibrillation(AF) at the time of stroke. 100 patients will be enrolled.",[132,133],"Atrial Fibrillation","Stroke","NOT_YET_RECRUITING","2025-08-27",{"date":137,"type":138},"2025-08-28","ACTUAL",{"date":140,"type":128},"2025-10",{"date":142,"type":128},"2027-06",{"name":5,"class":6},7]