[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06529978":3,"trial-entities:NCT06529978":119,"trial-summary:NCT06529978":123},{"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":41,"secondary_outcomes":50,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":105,"overall_officials":114,"references":117,"see_also_links":118},"NCT06529978","CD001","Endocardial Mapping With the CoreMap EP Mapping System","Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol","RECRUITING","2026-12-31","2026-07","2026-07-14","2024-07-25","CoreMap Inc.","INDUSTRY",false,"This is a global, multi-site, prospective, feasibility study.","The INvENI Study consists of three phases:\n\nPhase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.\n\nPhase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF.\n\nPhase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation. This phase aims to demonstrate safety and effectiveness compared to a control arm.",[19],"Persistent Atrial Fibrillation",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},245,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","CoreMap EP Mapping System Mapping","Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.",[34,35,36],"Phase 1- Mapping Only","Phase 2- Map Guided Ablation","Phase 3 - Map Guided Ablation",{"type":30,"name":38,"description":39,"armGroupLabels":40},"CoreMap EP Mapping System Map-Guided Ablation","Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.",[35,36],[42,46],{"measure":43,"description":44,"timeFrame":45},"Phases 1 and Phase 2 Primary Endpoint:","Incidence of study device related serious adverse events within seven (7) days of the study procedure.","7 days",{"measure":47,"description":48,"timeFrame":49},"Phase 2 and Phase 3 Primary Effectiveness Endpoint:","Freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through a 12-month follow-up and excluding a 90-day blanking period.","6 and 12 months",[51,55,58],{"measure":52,"description":53,"timeFrame":54},"Phase 1 Secondary Endpoint:","Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System.","perioperatively\u002Fperiprocedurally",{"measure":56,"description":57,"timeFrame":54},"Phase 2 Secondary Endpoints:","AF rhythm change or termination following CoreMap-guided ablation.",{"measure":59,"description":60,"timeFrame":54},"Phase 3 Secondary Endpoints:","AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm.","ALL","18 Years","80 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \\& 2)\n2. Subject has PerAF with no history of prior AF ablation therapy (Phase 3)\n3. Subject is 18 to 80 years of age\n4. Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)\n5. Subject is able to provide written informed consent\n6. Subject is able and willing to complete all study procedures\n\nExclusion Criteria:\n\n1. Any of the following within three months of enrollment:\n\n   1. Myocardial infarction (MI)\n   2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation\n   3. Confirmed thrombus on imaging\n2. Any of the following within six months of enrollment:\n\n   1. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy\n   2. Thromboembolic event (stroke)\n3. Any of the following cardiac conditions:\n\n   1. New York Heart Association (NYHA) IV\n   2. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n   3. Left atrial diameter \\>55mm (anterioposterior) (Phase 3)\n   4. Carotid stenting or endarterectomy\n   5. Atrial or ventricular septal closure or left atrial appendage closure\n   6. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.\n   7. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation\n   8. Unstable angina\n   9. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve\n   10. Moderate to severe mitral valve stenosis or other severe valvular disease\n   11. Any blood clotting or bleeding abnormalities\n4. Contraindication to systemic anticoagulation\n5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause\n6. Body mass index (BMI) \\> 40 kg\u002Fm2\n7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition\n8. Renal failure requiring dialysis or transplant\n9. Acute illness, active systemic infection, or sepsis\n10. Active drug or alcohol dependency\n11. Hypertrophic cardiomyopathy or cardiac amyloidosis\n12. Cor pulmonale\n13. Any contra-indication that may extend procedure time, at the discretion of the operator\n14. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n15. Subject considered part of vulnerable population\n16. Life expectancy less than one year\n17. Employee of the study site or Sponsor\n18. Subjects who are currently enrolled in another study that would directly interfere with this study",[69,70],"ADULT","OLDER_ADULT",[72,82,90,98],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"NCH Downtown Baker Hospital","ENROLLING_BY_INVITATION","Naples","Florida","34102","United States",{"lat":80,"lon":81},26.14234,-81.79596,{"facility":83,"status":74,"city":84,"state":85,"zip":86,"country":78,"geoPoint":87},"University of Vermont Medical Center","Burlington","Vermont","05401",{"lat":88,"lon":89},44.47588,-73.21207,{"facility":91,"status":74,"city":92,"state":93,"zip":94,"country":78,"geoPoint":95},"Virginia Commonwealth University (VCU)","Richmond","Virginia","23284",{"lat":96,"lon":97},37.55376,-77.46026,{"facility":99,"status":8,"city":100,"country":101,"geoPoint":102},"Na Homolce Hospital","Praha Klanovice","Czechia",{"lat":103,"lon":104},50.0974,14.66915,[106,111],{"name":107,"role":108,"phone":109,"email":110},"Jim Foster, SysEng","CONTACT","6178723908","jfoster@coremapmedical.com",{"name":112,"role":108,"email":113},"Sarah Kalil","skalil@coremapmedical.com",[115],{"name":112,"affiliation":13,"role":116},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Atrial Fibrillation",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":135},true,{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is a global, multi-site study that will enroll 245 participants. It has three phases, with some phases comparing the CoreMap system to a control group.","completed","CoreMap EP Mapping System for Persistent Atrial Fibrillation","This study is testing a new medical device called the CoreMap EP Mapping System for people with persistent atrial fibrillation (AF), a type of irregular heartbeat. The CoreMap system helps doctors understand your heart's electrical activity (endocardial mapping) and guide a procedure called ablation to correct the irregular rhythm. The study aims to see how safe and effective the CoreMap system is. For some participants, it will compare the CoreMap system to standard care. To join, you must be between 18 and 80 years old and have persistent or long-standing persistent AF. The study will look at how well the treatment works after 6 and 12 months. The study is currently recruiting 245 participants.","Your health will be checked at 7 days, and then again at 6 and 12 months after treatment.",114,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]