Arrhythmic Burden, Implantable Cardioverter-Defibrillator (ICD) Therapies, Slow-conduction Substrate, VT Ablation
Conditions
Brief summary
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
DEVICEACORYS Mapping System
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.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VT recurrence | 12 months | Recurrence of sustained ventricular tachycardia after the index ablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrophysiological endpoints | Baseline | 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 | 12 months | Effect of the APOLO-VT ablation strategy on ICD therapies, heart failure hospitalization, and all-cause mortality during follow-up. |
| Acute procedural outcomes | Baseline | 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 | Baseline | 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) |
Countries
Spain
Outcome results
None listed