[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06747013":3,"trial-entities:NCT06747013":102,"trial-summary:NCT06747013":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":42,"secondary_outcomes":47,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":83,"locations":86,"central_contacts":95,"overall_officials":96,"references":100,"see_also_links":101},"NCT06747013","STUDY-24-00971","Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA","ENROLLING_BY_INVITATION","2026-12","2026-07","2026-07-30","2025-01-07","Vivek Reddy","OTHER",true,"The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.","Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.\n\nSample Size - A total of 60 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.\n\nStudy Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.\n\nStudy Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.\n\nParticipant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.\n\nPrimary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (\\>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.",[18,19,20],"Focal Ventricular Arrhythmias","Premature Ventricular Contractions","Ventricular Tachycardias",[22,23,19,24,20,25],"Ventricular Arrhythmias","PVCs","VT","Symptomatic Sustained Monomorphic Ventricular Tachycardia","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},60,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"DEVICE","Point Ablation Catheter","a point ablation catheter using a pulse field energy",[39],"Ablation using study catheter",[41],"Farapoint",[43],{"measure":44,"description":45,"timeFrame":46},"Freedom from PVC\u002FVT recurrence","Freedom from PVC\u002FVT recurrence defined as a reduction in the burden of premature ventricular contracts (\\>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.\n\n(Sustained Focal Tachycardia is defined as that persisting for \\> 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope))","at 3 months following ablation procedure",[48,51,54],{"measure":49,"description":50,"timeFrame":46},"Incidence of Adverse events","Safety is measured as incidence of Serious Adverse Device Effects (SADEs)",{"measure":52,"description":53,"timeFrame":46},"Incidence of Serious Adverse Events (SAEs)","Safety is measured as incidence of Serious Adverse Events (SAEs)",{"measure":55,"description":56,"timeFrame":46},"Incidence of non-serious adverse events","Safety is measured as incidence of non-serious adverse events","ALL","18 Years",null,false,{"inclusion":62,"exclusion":67,"raw_text":82},[63,64,25,65,66],"Patient is planned for a catheter ablation procedure to ablate either:","Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS\u002FEHRA\u002FAPHRS\u002FLAHRS guidelines","Able and willing to provide written consent and comply with all testing and follow-up requirements","Above 18 years of age",[68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)","Contraindication to anticoagulation","Life expectancy or other disease processes likely to limit survival to less than 12 months.","Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.","NYHA Class IV heart failure","Severe, untreated coronary artery disease which would preclude infusion of provocative agents","Severe aortic stenosis (AVA \\\u003C 1.0cm, or PG \\> 64mmHg)","Severe mitral regurgitation.","Allergy to contrast which is unable to be adequately pre-medicated.","Acute non-cardiovascular illness or systemic infection","Thrombocytopenia (platelet count \\\u003C 50,000\u002Fmm3) or coagulopathy unless corrected","Cardiogenic shock unrelated to ventricular arrhythmias","Pregnancy or anticipated pregnancy during study follow-up","PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.","Inclusion Criteria:\n\nSubjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:\n\n* Patient is planned for a catheter ablation procedure to ablate either:\n\n  * Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS\u002FEHRA\u002FAPHRS\u002FLAHRS guidelines\n  * Symptomatic Sustained Monomorphic Ventricular Tachycardia\n* Able and willing to provide written consent and comply with all testing and follow-up requirements\n* Above 18 years of age\n\nExclusion Criteria:\n\n* Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)\n* Contraindication to anticoagulation\n* Life expectancy or other disease processes likely to limit survival to less than 12 months.\n* Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.\n* NYHA Class IV heart failure\n* Severe, untreated coronary artery disease which would preclude infusion of provocative agents\n* Severe aortic stenosis (AVA \\\u003C 1.0cm, or PG \\> 64mmHg)\n* Severe mitral regurgitation.\n* Allergy to contrast which is unable to be adequately pre-medicated.\n* Acute non-cardiovascular illness or systemic infection\n* Thrombocytopenia (platelet count \\\u003C 50,000\u002Fmm3) or coagulopathy unless corrected\n* Cardiogenic shock unrelated to ventricular arrhythmias\n* Pregnancy or anticipated pregnancy during study follow-up\n* PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":89,"zip":90,"country":91,"geoPoint":92},"Icahn School of Medicine at Mount Sinai","New York","10029","United States",{"lat":93,"lon":94},40.71427,-74.00597,[],[97],{"name":98,"affiliation":88,"role":99},"Vivek Reddy, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":107},[104,105,106],"Sustained monomorphic ventricular tachycardia","Ventricular Arrhythmia","Ventricular premature complex",[],{"nct_id":4,"found":60,"summary":59,"prompt_version":59}]