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Treatment Based on High Precision Cardiac Mapping: Advancing Personalized Outcomes Through Optimized Localization

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Spain
Hospital Clinic, University of Barcelona
RECRUITING
Barcelona
Time Frame
Start Date: 2026-07-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Ablation strategy
Ablation is guided by an integrated non-invasive mapping strategy, combining structural targets from late gadolinium enhancement cardiac magnetic resonance and/or functional targets (deceleration zones) from non-invasive Volumetric ECGi in sinus rhythm (SR) and pacing protocol; both are merged with invasive electroanatomic mapping. Before ablation, programmed stimulation assesses VT inducibility; if VT is induced, its Volumetric ECGi-derived critical isthmus is added as a further target. Lesions are delivered to these non-invasively defined target regions, with adequacy defined as loss of local capture on pacing at the ablation site. Afterwards, SR and paced Volumetric ECGi remapping reassesses residual deceleration zones, with further ablation and remapping if substrate persists. Programmed stimulation is repeated, with invasive remapping and ablation for validation. Acute procedural success requires VT non-inducibility and elimination of relevant functional substrate.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona

This content was sourced from clinicaltrials.gov