[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06324201":3,"trial-entities:NCT06324201":298,"trial-summary:NCT06324201":301},{"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":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":286,"overall_officials":291,"references":296,"see_also_links":297},"NCT06324201","QDOT PAS","The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.","The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO™ System Use in Conjunction With VISITAG SURPOINT™Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation","RECRUITING","2028-03","2025-10","2025-10-31","2024-02-27","Heart Rhythm Clinical and Research Solutions, LLC","OTHER",false,"Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.","Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. These enrolled subjects will be treated with the commercially available QDOT MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in conjunction with VISITAG SURPOINT™ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure. Retrospective consecutive patients from the REAL AF registry, who were ablated with the QDOT MICRO™ system, may be enrolled into the sub-study if the patient meets eligibility criteria and provides consent for additional follow-up of 24 and 36-months",[19],"Paroxysmal Atrial Fibrillation",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},250,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"DEVICE","Ablation Procedure","Ablation Procedure for paroxysmal atrial fibrillation",[33,37,41,45],{"measure":34,"description":35,"timeFrame":36},"Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module","Adverse events from post-procedure through 7-day post ablation visit.","Day 0-7 post ablation",{"measure":38,"description":39,"timeFrame":40},"Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.","Freedom from atrial arrhythmia recurrence at 12 months post procedure.","12 months",{"measure":42,"description":43,"timeFrame":44},"Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.","Freedom from atrial arrhythmia recurrence at 24 months post procedure.","24 months",{"measure":46,"description":47,"timeFrame":48},"Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.","Freedom from atrial arrhythmia recurrence at 36 months post procedure.","36 months",[],"ALL","18 Years",{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria:\n\n1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF\n2. 18 years of age or older\n3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study\n4. Willing and able to provide informed consent for this sub-study\n\nExclusion Criteria:\n\n1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)\n2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan\n3. Persistent or long-standing persistent AF\n4. In the opinion of the investigator, any known contraindication to an ablation procedure",[57,58],"ADULT","OLDER_ADULT",[60,73,83,94,105,114,124,135,146,158,169,179,190,197,208,218,232,242,252,263,273],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":70},"Arrhythmia Institute at Grandview","Birmingham","Alabama","35209","United States",[67],{"name":68,"role":69},"Anil Rajendra, MD","PRINCIPAL_INVESTIGATOR",{"lat":71,"lon":72},33.52066,-86.80249,{"facility":74,"status":8,"city":75,"state":63,"zip":76,"country":65,"contacts":77,"geoPoint":80},"Mobile Cardiology Associates","Mobile","36608",[78],{"name":79,"role":69},"Matthew E Quin, MD",{"lat":81,"lon":82},30.69436,-88.04305,{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":65,"contacts":88,"geoPoint":91},"Community Memorial Health System","Ventura","California","93003",[89],{"name":90,"role":69},"Jonathan Dukes, MD",{"lat":92,"lon":93},34.27834,-119.29317,{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":65,"contacts":99,"geoPoint":102},"Medical City - HCA","Aurora","Colorado","80012",[100],{"name":101,"role":69},"Christopher Porterfield, MD",{"lat":103,"lon":104},39.72943,-104.83192,{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":65,"geoPoint":111},"Naples Community Hospital","WITHDRAWN","Naples","Florida","34102",{"lat":112,"lon":113},26.14234,-81.79596,{"facility":115,"status":8,"city":116,"state":109,"zip":117,"country":65,"contacts":118,"geoPoint":121},"Sarasota Memorial Health","Sarasota","34239",[119],{"name":120,"role":69},"Antonio Moretta, MD",{"lat":122,"lon":123},27.33643,-82.53065,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":65,"contacts":129,"geoPoint":132},"Piedmont Healthcare","Atlanta","Georgia","30309",[130],{"name":131,"role":69},"Sandeep Goyal, MD",{"lat":133,"lon":134},33.749,-84.38798,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":65,"contacts":140,"geoPoint":143},"Norton Heart and Vascular Institute","Louisville","Kentucky","40205",[141],{"name":142,"role":69},"Kent Morris, MD",{"lat":144,"lon":145},38.25424,-85.75941,{"facility":147,"status":148,"city":149,"state":150,"zip":151,"country":65,"contacts":152,"geoPoint":155},"The Brigham and Womens Hospital","NOT_YET_RECRUITING","Boston","Massachusetts","02115",[153],{"name":154,"role":69},"Jorge Romero, MD",{"lat":156,"lon":157},42.35843,-71.05977,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":65,"contacts":163,"geoPoint":166},"Sparrow Clinical Research Institute","Lansing","Michigan","48912",[164],{"name":165,"role":69},"Ali Sheikh, DO",{"lat":167,"lon":168},42.73253,-84.55553,{"facility":170,"status":8,"city":171,"state":161,"zip":172,"country":65,"contacts":173,"geoPoint":176},"Trinity Health-Michigan Heart","Ypsilanti","48197",[174],{"name":175,"role":69},"Mohammad-Ali Jazayeri, MD",{"lat":177,"lon":178},42.24115,-83.61299,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":65,"contacts":184,"geoPoint":187},"The Christ Hospital","Cincinnati","Ohio","45219",[185],{"name":186,"role":69},"Alexandru Costea, MD",{"lat":188,"lon":189},39.12711,-84.51439,{"facility":191,"status":8,"city":181,"state":182,"zip":192,"country":65,"contacts":193,"geoPoint":196},"University of Cincinnati","45221",[194],{"name":195,"role":69},"Srinivas Rajsheker, MD",{"lat":188,"lon":189},{"facility":198,"status":8,"city":199,"state":200,"zip":201,"country":65,"contacts":202,"geoPoint":205},"University of Pennsylvania (UPENN)","Philadelphia","Pennsylvania","19104",[203],{"name":204,"role":69},"Benjamin D'Souza, MD",{"lat":206,"lon":207},39.95238,-75.16362,{"facility":209,"status":8,"city":210,"state":200,"zip":211,"country":65,"contacts":212,"geoPoint":215},"Allegheny Health","Pittsburgh","15212",[213],{"name":214,"role":69},"Joshua Silverstein, MD",{"lat":216,"lon":217},40.44062,-79.99589,{"facility":219,"status":8,"city":220,"state":221,"zip":222,"country":65,"contacts":223,"geoPoint":229},"Centra Health, Inc.dba Stroobants Cardiovascular Center","Lynchburg","Virginia","24501",[224,227],{"name":225,"role":226},"Cindy Baumann","CONTACT",{"name":228,"role":69},"Mathhew Sackett",{"lat":230,"lon":231},37.41375,-79.14225,{"facility":233,"status":8,"city":234,"state":221,"zip":235,"country":65,"contacts":236,"geoPoint":239},"Bon Secours Medical Group - Richmond Specialty Care","Richmond","23226",[237],{"name":238,"role":69},"An Bui, MD",{"lat":240,"lon":241},37.55376,-77.46026,{"facility":243,"status":8,"city":244,"state":221,"zip":245,"country":65,"contacts":246,"geoPoint":249},"Valley Health System","Winchester","22601",[247],{"name":248,"role":69},"Emmanuel Ekanem, MD",{"lat":250,"lon":251},39.18566,-78.16333,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":65,"contacts":257,"geoPoint":260},"Multicare Health Systems-Pulse Heart","Puyallup","Washington","98372",[258],{"name":259,"role":69},"Tariq Salam, MD",{"lat":261,"lon":262},47.18538,-122.2929,{"facility":264,"status":8,"city":265,"state":255,"zip":266,"country":65,"contacts":267,"geoPoint":270},"Franciscan Heart and Vascular Associates","Tacoma","98401",[268],{"name":269,"role":69},"Nasir Shariff, MD",{"lat":271,"lon":272},47.25288,-122.44429,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":65,"contacts":278,"geoPoint":283},"Mercy Health","Janesville","Wisconsin","53548",[279,281],{"name":280,"role":226},"Kaitlyn Phetteplace",{"name":282,"role":69},"Imdad Ahmed",{"lat":284,"lon":285},42.68279,-89.01872,[287],{"name":288,"role":226,"phone":289,"email":290},"Jennifer Moss","615-448-5770","jmoss@hrcrs.com",[292],{"name":293,"affiliation":294,"role":295},"Brian Sanchez, MD","J & J Corporation","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":299,"biomarkers":300},[19],[],{"nct_id":4,"found":302,"summary":303,"prompt_version":313},true,{"design":304,"status":305,"heading":306,"summary":307,"follow_up":308,"word_count":309,"commitments":310,"compensation":311,"drugs_mentioned":312},"This is an observational study, meaning researchers will watch how the QDOT MICRO System is used in real-world settings. It is a sub-study within a larger registry, and it is not randomized.","completed","Evaluating the QDOT MICRO System for Atrial Fibrillation","This study is looking at the long-term safety and effectiveness of a medical device called the QDOT MICRO System, used with the VISITAG SURPOINT Module, to treat symptomatic paroxysmal atrial fibrillation (a type of irregular heartbeat that starts and stops on its own). Researchers want to see how well this system works and if it's safe for people who haven't responded to other treatments. You might be able to join if you are 18 or older, have this type of atrial fibrillation, and your doctor thinks you could benefit from an ablation procedure (a treatment that uses heat or cold to create tiny scars in the heart to block faulty electrical signals). The study aims to enroll 250 participants, but its current status is unclear.","Participants will be followed for safety for 7 days after the procedure, and for effectiveness at 12 months, 24 months, and 36 months.",125,"You would need to complete scheduled assessments within 12 months after your ablation procedure, and then two more assessments at 24 and 36 months.","Not stated in the trial record.",[30],"v2"]