[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06455098":3,"trial-entities:NCT06455098":388,"trial-summary:NCT06455098":391},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":44,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":88,"locations":91,"central_contacts":381,"overall_officials":382,"references":386,"see_also_links":387},"NCT06455098","BWI202303","A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)","Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter","ACTIVE_NOT_RECRUITING","2027-07-31","2026-08","2026-08-31","2024-06-28","Biosense Webster, Inc.","INDUSTRY",false,"The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.",null,[19],"Atrial Fibrillation",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},353,"ACTUAL",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","OMNYPULSE™ Catheter with the TRUPULSE Generator","OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.",[34],"Pulsed Field (PF) Ablation System",[36,40],{"measure":37,"description":38,"timeFrame":39},"Number of Participants with Primary Adverse Events (PAEs)","Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade\u002Fperforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke\u002Fcerebrovascular accident (CVA), major vascular access complication\u002Fbleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury\u002Fgastroparesis.","7 days post-procedure",{"measure":41,"description":42,"timeFrame":43},"Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes","Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of \\>= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.","Day 91 to Day 365 post-procedure",[45],{"measure":46,"description":47,"timeFrame":48},"Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score","The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding \"extremely\" difficult 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). A positive change in score corresponds to improvement in AF symptoms.","Baseline, Month 12","ALL","18 Years","80 Years",{"inclusion":53,"exclusion":58,"raw_text":87},[54,55,56,57],"Diagnosed with symptomatic paroxysmal AF with:","Failed at least one Class I or Class III antiarrhythmic drug","Willing and capable to provide consent","Able and willing to comply with all pre-, post- and follow-up testing and requirements",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],"Previously diagnosed with persistent AF (greater than \\[\\>\\] 7 days in duration)","AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.","Previous surgical or catheter ablation for AF","Patients known to require ablation outside the PV ostia and outside the CTI region.","Documented severe dilatation of the left atrium (LAD\\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment","Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure","Documented severely compromised left ventricular ejection fraction (LVEF \\\u003C40%) by imaging within 6 months prior to enrollment","Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV","History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)","Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months","Previous Percutaneous Coronary Intervention (PCI)\u002F myocardial infarction \\[MI\\] within the past 2 months","Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months","Valvular cardiac surgical\u002Fpercutaneous procedure","Unstable angina within 6 months","Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months","Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms","Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study","Prior diagnosis of pulmonary vein stenosis","Pre-existing hemi diaphragmatic paralysis","Acute illness, active systemic infection, or sepsis","Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation","Severe mitral regurgitation","Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)","Presence of a condition that precludes vascular access","Current enrollment in an investigational study evaluating another device or drug","Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation","Life expectancy less than 12 months","Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)","Inclusion Criteria:\n\n* Diagnosed with symptomatic paroxysmal AF with:\n\n  1. At least two symptomatic AF episodes within last six months from enrollment\n  2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment\n* Failed at least one Class I or Class III antiarrhythmic drug\n* Willing and capable to provide consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent AF (greater than \\[\\>\\] 7 days in duration)\n* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.\n* Previous surgical or catheter ablation for AF\n* Patients known to require ablation outside the PV ostia and outside the CTI region.\n* Documented severe dilatation of the left atrium (LAD\\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment\n* Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure\n* Documented severely compromised left ventricular ejection fraction (LVEF \\\u003C40%) by imaging within 6 months prior to enrollment\n* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months\n* Previous Percutaneous Coronary Intervention (PCI)\u002F myocardial infarction \\[MI\\] within the past 2 months\n* Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months\n* Valvular cardiac surgical\u002Fpercutaneous procedure\n* Unstable angina within 6 months\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* Acute illness, active systemic infection, or sepsis\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Severe mitral regurgitation\n* Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)\n* Presence of a condition that precludes vascular access\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)",[89,90],"ADULT","OLDER_ADULT",[92,101,109,116,123,130,138,146,154,158,165,172,179,187,191,194,201,209,217,225,229,237,245,253,261,268,272,276,283,290,298,306,314,321,329,336,344,352,359,366,374],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"Phoenix Cardiovascular Research Group","Phoenix","Arizona","85018","United States",{"lat":99,"lon":100},33.44838,-112.07404,{"facility":102,"city":103,"state":104,"zip":105,"country":97,"geoPoint":106},"Mills Peninsula Health Services","Burlingame","California","94010",{"lat":107,"lon":108},37.5841,-122.36608,{"facility":110,"city":111,"state":104,"zip":112,"country":97,"geoPoint":113},"Cardiovascular Associates of Marin","Larkspur","94939",{"lat":114,"lon":115},37.93409,-122.53525,{"facility":117,"city":118,"state":104,"zip":119,"country":97,"geoPoint":120},"Hoag Memorial Hospital","Newport Beach","92663",{"lat":121,"lon":122},33.61891,-117.92895,{"facility":124,"city":125,"state":104,"zip":126,"country":97,"geoPoint":127},"San Diego Cardiac Center","San Diego","92123",{"lat":128,"lon":129},32.71571,-117.16472,{"facility":131,"city":132,"state":133,"zip":134,"country":97,"geoPoint":135},"University of Colorado","Aurora","Colorado","80045",{"lat":136,"lon":137},39.72943,-104.83192,{"facility":139,"city":140,"state":141,"zip":142,"country":97,"geoPoint":143},"Hartford Hospital","Hartford","Connecticut","06102",{"lat":144,"lon":145},41.76371,-72.68509,{"facility":147,"city":148,"state":149,"zip":150,"country":97,"geoPoint":151},"Ascension St. Vincent's","Jacksonville","Florida","32204",{"lat":152,"lon":153},30.33218,-81.65565,{"facility":155,"city":148,"state":149,"zip":156,"country":97,"geoPoint":157},"Baptist Health Research Institute","32207",{"lat":152,"lon":153},{"facility":159,"city":160,"state":149,"zip":161,"country":97,"geoPoint":162},"HCA Florida Mercy Hospital","Miami","33133",{"lat":163,"lon":164},25.77427,-80.19366,{"facility":166,"city":167,"state":149,"zip":168,"country":97,"geoPoint":169},"NCH Healthcare","Naples","34102",{"lat":170,"lon":171},26.14234,-81.79596,{"facility":173,"city":174,"state":149,"zip":175,"country":97,"geoPoint":176},"Advent Health Orlando","Orlando","32803",{"lat":177,"lon":178},28.53834,-81.37924,{"facility":180,"city":181,"state":182,"zip":183,"country":97,"geoPoint":184},"Piedmont Healthcare","Atlanta","Georgia","30309",{"lat":185,"lon":186},33.749,-84.38798,{"facility":188,"city":181,"state":182,"zip":189,"country":97,"geoPoint":190},"Emory Saint Joseph's Hospital","30342",{"lat":185,"lon":186},{"facility":192,"city":181,"state":182,"zip":189,"country":97,"geoPoint":193},"Northside Hospital",{"lat":185,"lon":186},{"facility":195,"city":196,"state":182,"zip":197,"country":97,"geoPoint":198},"Memorial Health University Medical Center","Savannah","31404",{"lat":199,"lon":200},32.08354,-81.09983,{"facility":202,"city":203,"state":204,"zip":205,"country":97,"geoPoint":206},"NorthShore University Medical Center","Glenview","Illinois","60026",{"lat":207,"lon":208},42.06975,-87.78784,{"facility":210,"city":211,"state":212,"zip":213,"country":97,"geoPoint":214},"Johns Hopkins","Baltimore","Maryland","21287",{"lat":215,"lon":216},39.29038,-76.61219,{"facility":218,"city":219,"state":220,"zip":221,"country":97,"geoPoint":222},"Massachusetts General","Boston","Massachusetts","02114",{"lat":223,"lon":224},42.35843,-71.05977,{"facility":226,"city":219,"state":220,"zip":227,"country":97,"geoPoint":228},"Brigham And Women's Hospital","02115",{"lat":223,"lon":224},{"facility":230,"city":231,"state":232,"zip":233,"country":97,"geoPoint":234},"Beaumont Health Systems","Royal Oak","Michigan","48073",{"lat":235,"lon":236},42.48948,-83.14465,{"facility":238,"city":239,"state":240,"zip":241,"country":97,"geoPoint":242},"Minneapolis Heart Institute","Minneapolis","Minnesota","55414",{"lat":243,"lon":244},44.97997,-93.26384,{"facility":246,"city":247,"state":248,"zip":249,"country":97,"geoPoint":250},"Morristown Medical Center","Morristown","New Jersey","07960",{"lat":251,"lon":252},40.79677,-74.48154,{"facility":254,"city":255,"state":256,"zip":257,"country":97,"geoPoint":258},"New Mexico Heart Institute","Albuquerque","New Mexico","87102",{"lat":259,"lon":260},35.08449,-106.65114,{"facility":262,"city":263,"state":263,"zip":264,"country":97,"geoPoint":265},"Mount Sinai School of Medicine","New York","10029",{"lat":266,"lon":267},40.71427,-74.00597,{"facility":269,"city":263,"state":263,"zip":270,"country":97,"geoPoint":271},"New York Presbyterian - Weill Cornell Medical Ctr","10065",{"lat":266,"lon":267},{"facility":273,"city":263,"state":263,"zip":274,"country":97,"geoPoint":275},"Lenox Hill Hospital","10075",{"lat":266,"lon":267},{"facility":277,"city":278,"state":263,"zip":279,"country":97,"geoPoint":280},"St Francis Hospital","Roslyn","11576",{"lat":281,"lon":282},40.79982,-73.65096,{"facility":284,"city":285,"state":263,"zip":286,"country":97,"geoPoint":287},"Montefiore Medical Center","The Bronx","10467",{"lat":288,"lon":289},40.84985,-73.86641,{"facility":291,"city":292,"state":293,"zip":294,"country":97,"geoPoint":295},"WakeMed Heart & Vascular","Raleigh","North Carolina","27610",{"lat":296,"lon":297},35.7721,-78.63861,{"facility":299,"city":300,"state":301,"zip":302,"country":97,"geoPoint":303},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":304,"lon":305},41.4995,-81.69541,{"facility":307,"city":308,"state":309,"zip":310,"country":97,"geoPoint":311},"University of Pennsylvania Health System","Philadelphia","Pennsylvania","19104",{"lat":312,"lon":313},39.95238,-75.16362,{"facility":315,"city":316,"state":309,"zip":317,"country":97,"geoPoint":318},"York Hospital","York","17403",{"lat":319,"lon":320},39.9626,-76.72774,{"facility":322,"city":323,"state":324,"zip":325,"country":97,"geoPoint":326},"Texas Cardiac Arrhythmia Research Foundation","Austin","Texas","78705",{"lat":327,"lon":328},30.26715,-97.74306,{"facility":330,"city":331,"state":324,"zip":332,"country":97,"geoPoint":333},"Texas Heart Institute","Houston","77030",{"lat":334,"lon":335},29.76328,-95.36327,{"facility":337,"city":338,"state":339,"zip":340,"country":97,"geoPoint":341},"Intermountain Medical Center","Murray","Utah","84107",{"lat":342,"lon":343},40.66689,-111.88799,{"facility":345,"city":346,"state":347,"zip":348,"country":97,"geoPoint":349},"Inova Fairfax Medical Campus- Inova Heart and Vascular Institute","Falls Church","Virginia","22042",{"lat":350,"lon":351},38.88233,-77.17109,{"facility":353,"city":354,"state":347,"zip":355,"country":97,"geoPoint":356},"Sentara Norfolk General Hospital","Norfolk","23507",{"lat":357,"lon":358},36.84681,-76.28522,{"facility":360,"city":361,"state":347,"zip":362,"country":97,"geoPoint":363},"Virginia Commonwealth University","Richmond","23298",{"lat":364,"lon":365},37.55376,-77.46026,{"facility":367,"city":368,"zip":369,"country":370,"geoPoint":371},"Royal Adelaide Hospital","Adelaide","5000","Australia",{"lat":372,"lon":373},-34.92866,138.59863,{"facility":375,"city":376,"zip":377,"country":370,"geoPoint":378},"Royal Melbourne Hospital","Parkville","03052",{"lat":379,"lon":380},-37.78333,144.95,[],[383],{"name":384,"affiliation":13,"role":385},"Biosense Webster, Inc. Clinical Trial","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":389,"biomarkers":390},[19],[],{"nct_id":4,"found":392,"summary":393,"prompt_version":403},true,{"design":394,"status":395,"heading":396,"summary":397,"follow_up":398,"word_count":399,"commitments":400,"compensation":401,"drugs_mentioned":402},"This is an interventional study planning to enroll 440 participants. The phase of the study is not specified.","completed","A Study of OMNYPULSE Catheter for Paroxysmal Atrial Fibrillation","This study is testing the safety and effectiveness of a new treatment called BWI OMNYPULSE™ pulsed field ablation (PFA) for people with paroxysmal atrial fibrillation (PAF). PAF is an irregular heart rhythm that causes abnormal blood flow. The treatment uses the OMNYPULSE™ Catheter with the TRUPULSE™ Generator to isolate areas in the heart. We are looking for 440 participants, aged 18 to 80, who have symptomatic PAF and have not responded to at least one antiarrhythmic drug. The study will measure how many participants experience adverse events within 7 days and how many remain free from irregular heart rhythms for up to 12 months after the procedure. The current status of this study is unclear.","Participants will be followed for primary adverse events for 7 days after the procedure, and for freedom from atrial tachyarrhythmia for up to 365 days (12 months).",115,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]