Treatment Based on High Precision Cardiac Mapping

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital Clinic of Barcelona

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Ablation strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VT recurrence

Recurrence of sustained ventricular tachycardia after the index ablation.

Time frame
12 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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