About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
ACORYS Mapping System
DeviceADAS 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.
Treatment groups
Trial outcomes
Primary outcomes
VT recurrence
Recurrence of sustained ventricular tachycardia after the index ablation.
Secondary outcomes
Acute procedural outcomes
Rate of acute procedural success, defined as non-inducibility of sustained monomorphic ventricular tachycardia and absence of relevant residual deceleration zones on post-ablation remapping. Procedural efficiency (procedure duration, fluoroscopy time, radiofrequency application time).
Procedure complications
Acute and late complications related to ablation (vascular complications, tamponade, stroke, and mortality) as well as late complications (pericarditis, phrenic nerve injury, device-related events)
Electrophysiological endpoints
Correlation between non-invasive structural and functional targets (defined by the APOLO-VT ablation strategy) and invasive electrogram characteristics (low-voltage zones, fractionated or late potentials). Assessment of whether these non-invasive targets predict VT inducibility after ablation.
Clinical outcomes during follow-up
Effect of the APOLO-VT ablation strategy on ICD therapies, heart failure hospitalization, and all-cause mortality during follow-up.
Sponsors and contacts
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