Treatment Based on High Precision Cardiac Mapping

Phase 4RecruitingNCT07746336

Hospital Clinic of Barcelona60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

ACORYS Mapping SystemDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

VT recurrence

Recurrence of sustained ventricular tachycardia after the index ablation.

Time frame: 12 months

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).

Time frame: Baseline

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)

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: 12 months

Treatment Based on High Precision Cardiac Mapping

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes