[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06464315":3,"trial-entities:NCT06464315":115,"trial-summary:NCT06464315":119},{"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":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":48,"secondary_outcomes":53,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":95,"locations":98,"central_contacts":108,"overall_officials":109,"references":113,"see_also_links":114},"NCT06464315","CARA-007-23F","Functional Substrate-Only Guided VT Ablation","Functional Substrate-Only Mapping Technique to Guide Ablation of Arrhythmogenic Substrate Underlying Ventricular Tachycardia","ENROLLING_BY_INVITATION","2030-04-01","2026-03","2026-03-25","2026-03-18","VA Office of Research and Development","FED",true,"Ventricular tachycardia (VT) is a leading cause of death and suffering in the Veteran population. Currently, ablation procedures are performed to destroy the diseased tissue that causes this problem. This study will test to see if an experimental strategy of only targeting regions of slow conduction without the induction of VT can improve the efficacy and safety of VT ablation. Once this study is completed, the investigators will know whether this ablation strategy could help increase the efficacy, safety and efficiency of ablation therapy of fatal heart rhythms.","Ventricular tachycardia (VT) remains a leading cause of death and morbidity in the veteran population, but current ablation procedures to treat VT are limited by hemodynamic instability of induced VT during standard invasive activation mapping (up to 80% of induced VT), lengthy ablation procedures (\\~8 hours), and difficulty in accurately localizing the critical origination sites of VT. The long-term goal is to simplify VT ablation using invasive functional substrate mapping techniques to improve the safety, efficacy, and efficiency of VT catheter ablation. The overall objectives in this application are to i) perform a randomized clinical trial to test whether performing simplified VT ablation guided only by invasive functional substrate mapping without VT induction improves the safety and efficiency of VT ablation while maintaining similar efficacy compared to standard ablation and ii) mechanistically correlate abnormal functional substrate with VT origination sites localized using gold standard invasive activation mapping. The central hypothesis is that ablation of slowly conducting tissue characterized by high frequency signals is sufficient to eliminate VT and improves clinical outcomes of VT ablation. The rationale is that recently developed sophisticated techniques to characterize functionally abnormal tissue can localize critical VT-sustaining substrate without needing to subjecting patients to mapping of hemodynamically unstable VT which is routinely done during standard of care ablation. The central hypothesis will be tested by pursuing one primary specific aim: Perform a randomized clinical trial to determine whether VT ablation guided only by invasive functional substrate mapping without VT induction decreases procedure time, fluoroscopy time, and procedural complications while maintaining similar efficacy compared to standard VT ablation controls. This study also includes 2 sub-aims to uncover VT mechanisms characterizing the distance of slowly conducting tissue to VT exit sites and provide a method to unmask critical arrhythmogenic substrate in non-ischemic cardiomyopathy patients in whom scar is not easily identified. The research proposed is innovative because it tests a novel strategy using new algorithms that can identify the critical tissue sustaining VT without requiring the induction of VT. The proposed research is significant because a functional substrate-guided only approach to VT ablation while still localizing the critical tissue causing VT is expected to increase the safety, efficacy, and efficiency of treating a fatal heart rhythm disorder",[19,20],"Ventricular Tachycardia","Sudden Cardiac Death",[22,23,24,25,26],"functional substrate mapping","conduction slowing","isochronal late activation mapping (ILAM)","peak frequency signal analysis","deceleration zones","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},36,"ESTIMATED",[35,43],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"PROCEDURE","Functional Substrate-Only Mapping without VT Induction","In this arm, invasive maps will be constructed by annotating the latest deflection and peak frequency during voltage mapping of stable intrinsic rhythm to localize areas of slow conduction. Annotated algorithms are cleared by the FDA. No VT will be purposefully induced in this experimental arm.",[40],"Functional substrate mapping only without VT induction",[42],"Isochronal late activation mapping (ILAM), peak frequency analysis",{"type":36,"name":44,"description":45,"armGroupLabels":46},"Standard-of-Care Mapping\u002FImaging","Conventional invasive scar (voltage) and electrical VT (entrainment, activation, pace) mapping will be used to guide VT ablation. Functional substrate mapping will not be used in this arm. VT will be induced using standard protocols.",[47],"Standard VT Mapping",[49],{"measure":50,"description":51,"timeFrame":52},"Time to composite endpoint (VT recurrence, death, or acute hemodynamic decompensation)","Ventricular arrhythmia recurrence is defined by an episode of sustained VT lasting 30 seconds or appropriate implantable cardioverter-defibrillator therapy including anti-tachycardia pacing or shock.\n\nAcute hemodynamic decompensation is defined by escalation of at least 1 new high dose inotrope\u002Fpressor occurring after anesthesia induction with persistent requirement during stable rhythm, \\>20% drop in cardiac index, unplanned insertion of percutaneous hemodynamic support device.","6 months",[54,57,61,64,67,71,74],{"measure":55,"description":56,"timeFrame":52},"VT burden (ICD therapy including shocks and ATP, sustained VT episodes >30 seconds)","Total number of ICD therapies (ATP and shocks) and recorded sustained VT episodes\\>30 seconds, compared 6 months before and 6 months after ablation.",{"measure":58,"description":59,"timeFrame":60},"Total Mapping Time","dwell time of multi-electrode mapping catheters","immediately at the end of the procedure",{"measure":62,"description":63,"timeFrame":60},"Total fluoroscopy time","Total amount of fluoroscopy time during the entire procedure",{"measure":65,"description":66,"timeFrame":60},"total procedural time","time from introduction of catheters to removal of catheters",{"measure":68,"description":69,"timeFrame":70},"Procedural adverse events or complications","Major complications include: new acute pericardial effusion requiring intervention, vascular complication requiring intervention, embolic stroke confirmed by brain imaging, limb ischemia requiring intervention, or bacteremia.\n\nMajor adverse events include: cardiogenic shock (requiring escalation of inotropes or salvage mechanical circulatory support)","1 month",{"measure":72,"description":73,"timeFrame":60},"Use of general anesthesia","Whether general anesthesia (intubation) is required\u002Fused during the procedure",{"measure":75,"description":76,"timeFrame":70},"Acute heart failure readmission","unexpected readmission after index ablation discharge","ALL","18 Years","90 Years",false,{"inclusion":82,"exclusion":86,"raw_text":94},[83,84,85],"Men and women \\>18 years of age referred for clinically indicated VT ablation and experience monomorphic or polymorphic scar-based VT documented by telemetry, ICD interrogation, ECG or event monitoring.","Scar-based VT is defined as VT in patients with structural heart disease (assessed with either abnormal nuclear perfusion imaging (\\>5% defect), late gadolinium uptake on cardiac MRI, wall thinning \\\u003C10mm or calcified myocardium on cardiac CT, akinesis or hypokinesis on echocardiogram, presence of Q waves on ECG, history of myocardial infarct).","Patients undergoing epicardial VT ablation and who undergo prophylactic percutaneous hemodynamic support devices will also be included.",[87,88,89,90,91,92,93],"Patients without structural heart disease will be excluded from the pri-mary analysis, but enrolled in a prospective registry","Patients who are pregnant","Presence of intracardiac thrombus","active acute coronary ischemia with unrevascularized coronary artery disease (CAD \\>70% stenosis)","Active bacteremia","Inaccessible ventricles due to dual mechanical valves","Inability to tolerate and inability to tolerate anticoagulation during ablation and for at least 1 month after ablation","Inclusion Criteria:\n\n* Men and women \\>18 years of age referred for clinically indicated VT ablation and experience monomorphic or polymorphic scar-based VT documented by telemetry, ICD interrogation, ECG or event monitoring.\n* Scar-based VT is defined as VT in patients with structural heart disease (assessed with either abnormal nuclear perfusion imaging (\\>5% defect), late gadolinium uptake on cardiac MRI, wall thinning \\\u003C10mm or calcified myocardium on cardiac CT, akinesis or hypokinesis on echocardiogram, presence of Q waves on ECG, history of myocardial infarct).\n* Patients undergoing epicardial VT ablation and who undergo prophylactic percutaneous hemodynamic support devices will also be included.\n\nExclusion Criteria:\n\n* Patients without structural heart disease will be excluded from the pri-mary analysis, but enrolled in a prospective registry\n* Patients who are pregnant\n* Presence of intracardiac thrombus\n* active acute coronary ischemia with unrevascularized coronary artery disease (CAD \\>70% stenosis)\n* Active bacteremia\n* Inaccessible ventricles due to dual mechanical valves\n* Inability to tolerate and inability to tolerate anticoagulation during ablation and for at least 1 month after ablation",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"VA San Diego Healthcare System, San Diego, CA","San Diego","California","92161-0002","United States",{"lat":106,"lon":107},32.71571,-117.16472,[],[110],{"name":111,"affiliation":100,"role":112},"Gordon Ho, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117,20,19],"Structural Heart Disease",[],{"nct_id":4,"found":80,"summary":120,"prompt_version":120},null]