[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07275151":3,"trial-entities:NCT07275151":99,"trial-summary:NCT07275151":102},{"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":37,"sex":47,"minimum_age":48,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":91,"overall_officials":96,"references":97,"see_also_links":98},"NCT07275151","CVPFA-002","Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA","Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation. REFINE-PFA","RECRUITING","2026-12-31","2026-07","2026-07-23","2026-07-22","CathVision ApS","INDUSTRY",false,"The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.","Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a five-fold increase in stroke. Pulmonary vein isolation (PVI) has become accepted treatment for AF. Historically, this has been achieved using thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures. However, the catheters designed to deliver PFA differ to those used previously and may not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have durably isolated the pulmonary vein. This exploratory observational study will assess the utility of a software module designed to measure the local potential derived from the unipolar electrogram recorded at the electrode that has delivered the PFA. During the procedure, the study will collect data only and all analysis of the output of the PFAnalyzer software module will be made off-line once the procedure is complete. The operator will follow the hospital's standard of care during the procedure, and the software module will not be used to guide therapy, nor will there be any additional time added to the procedure.\n\nThe study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.",[19],"Atrial Fibrillation",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},40,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"DEVICE","Pulmonary vein isolation ablation","Electrical isolation of the pulmonary veins to treat atrial fibrillation",[33],{"measure":34,"description":35,"timeFrame":36},"Pulmonary vein isolation","assess the agreement between pulmonary vein isolation status as determined by the operator using entrance block as well as exit block during PV pacing and as classified by the PFAnalyzer software based on unipolar local potential characteristics analyzed off-line, post procedure.","intra-procedural",[38,41,44],{"measure":39,"description":40,"timeFrame":36},"Clinical utility","Assessment of the operators' subjective experience of clinical utility of the PFAnalyzer software measured through a 17-item questionnaire.",{"measure":42,"description":43,"timeFrame":36},"Identify a clinically meaningful threshold for residual potentials after PFA delivery.","Identify a clinically meaningful threshold for residual potentials after PFA delivery by comparing the amplitude of manually expert labelled local potentials to none local potential signals.",{"measure":45,"description":46,"timeFrame":36},"Feasibility of guiding rotation","Determine the feasibility of using PFAnalyzer to assist in optimizing rotation and placement of the catheter by measuring changes in local potential amplitude during rotation.","ALL","21 Years",{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\nEligible subjects will meet all of the following inclusion criteria:\n\n1. Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation.\n2. Male or non-pregnant female aged ≥21 years.\n3. Able and willing to provide written informed consent prior to any clinical investigation related procedure.\n4. Subjects in sinus rhythm at the time of the PFA application.\n\nExclusion Criteria:\n\nEligible subjects will not meet any of the following exclusion criteria:\n\n1. Pregnant or nursing subjects.\n2. Current participation in another investigational drug or device study that interferes with this study.\n3. Subjects who, in the opinion of the investigator, are not candidates for this study.\n4. Patients who have had a prior ablation procedure.\n5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n6. Life expectancy is less than 12 months, in the opinion of the investigator.\n7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.\n8. Subjects unlikely to be in sinus rhythm at the time of the procedure or unlikely to remain in sinus rhythm after cardioversion",[54,55],"ADULT","OLDER_ADULT",[57,75],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"Trinity Health Ann Arbor Hospital","NOT_YET_RECRUITING","Ypsilanti","Michigan","48197","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Xu Gao, MD","CONTACT","734-712-7787","Xu_Gao@michiganheart.com",{"name":66,"role":71},"PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},42.24115,-83.61299,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":63,"contacts":80,"geoPoint":88},"The Valley Hospital","Paramus","New Jersey","07652",[81,85,87],{"name":82,"role":67,"phone":83,"email":84},"Dan Musat, MD","201-432-7837","musada@valleyhealth.com",{"name":86,"role":67},"Jessica Mailim, RN",{"name":82,"role":71},{"lat":89,"lon":90},40.94454,-74.07542,[92],{"name":93,"role":67,"phone":94,"email":95},"Karl P Firth, MSc","+45 31324745","kpf@cathvision.com",[],[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[19],[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study with 40 participants. It is designed to explore how a specific software works during a medical procedure.","completed","Observational Study of Pulsed Field Ablation for Atrial Fibrillation","This study, called REFINE-PFA, is looking at a new way to treat atrial fibrillation (AF), a common heart rhythm problem. It focuses on a procedure called pulmonary vein isolation (PVI) using a newer method called pulsed field ablation (PFA). PFA uses short bursts of energy and is thought to be safer for nearby organs compared to older methods. Researchers will use a special software called PFAnalyzer with the ECGenius® System during PFA procedures to see how well it measures the electrical signals that show if the treatment worked. They want to see if this software can help doctors understand if the pulmonary veins are successfully isolated. You might be able to join if you are at least 21 years old, have atrial fibrillation, and are having PVI for the first time using the FaraPulse PFA system. The main goal is to see if the pulmonary veins are isolated during the procedure.","The primary endpoint, pulmonary vein isolation, is measured during the procedure (intra-procedural).",151,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]