RECRUITING Phase 4 ClinicalTrials.gov

Treatment Based on High Precision Cardiac Mapping

Sponsor: Hospital Clinic of Barcelona • ClinicalTrials.gov ID: NCT07746336

Registry updated: 2026-08-25

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Description

APOLO-VT aims to evaluate the feasibility, safety, and clinical impact of an integrated multimodal mapping workflow combining non-invasive structural and functional substrate characterization using Volumetric Electrocardiographic Imaging (ECGi) with invasive Electroanatomical Mapping (EAM) to support Ventricular tachycardia (VT) ablation targeting and verification.

Interventions

ACORYS Mapping System (Device)
ADAS 3D (ADAS 3D Medical, Barcelona; CE 714517) and the ACORYS Mapping System (Corify Care SL, Madrid; CE 775709) are two independently operating, CE-marked devices used within their approved intended use. ADAS 3D processes cardiac magnetic resonance images to characterize myocardial scar, border zone, and conduction corridors. ACORYS performs non-invasive electrocardiographic mapping, importing the ADAS 3D-derived anatomy to contextualize its electrophysiological maps. The structural and functional information from both devices is reviewed by the treating electrophysiologist as decision-support information, alongside invasive electroanatomic mapping; the ablation strategy and all treatment decisions remain at the physician's clinical discretion.

Eligibility criteria

Inclusion criteria * Age ≥18 years. * Diagnosis of structural heart disease (ischemic or non-ischemic cardiomyopathy). * Documented sustained monomorphic VT (clinical or inducible), or recurrent ICD therapies for VT. * Scheduled for catheter ablation of VT according to current international guidelines. * Ability to provide written informed consent. * Ability to remain upright or seated to allow a video for 3D torso reconstruction for ECGi acquisition. Exclusion criteria * Age \<18 years. * Pregnant or breastfeeding women. * Inability to provide informed consent due to physical or mental condition. * Contraindication to computed tomography or cardiac magnetic resonance (magnetic resonance imaging-incompatible devices, claustrophobia). * Contraindication to contrast agents (gadolinium allergy or severe renal dysfunction with estimated glomerular filtration rate \<30 mL/min/1.73 m²). * Inability to remain upright for torso 3D reconstruction required for ECGi. * Life expectancy \<1 year due to non-cardiac comorbidity.

Conditions

VT Ablation Arrhythmic Burden Implantable Cardioverter-Defibrillator (ICD) Therapies Slow-conduction Substrate

Locations

Hospital Clinic, University of Barcelona — Barcelona, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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