Not yet recruiting NCT07746336
Treatment Based on High Precision Cardiac Mapping
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACORYS Mapping System.
- Who it may be relevant to
- Registry conditions: VT Ablation, Arrhythmic Burden, Implantable Cardioverter-Defibrillator (ICD) Therapies, Slow-conduction Substrate. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment Based on High Precision Cardiac Mapping: Advancing Personalized Outcomes Through Optimized Localization
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.
Interventions
- Device ACORYS 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 functi
Primary outcome measures
- VT recurrence [Time frame: 12 months]
Secondary outcome measures (4)
- Acute procedural outcomes [Time frame: Baseline]
- Procedure complications [Time frame: Baseline]
- Electrophysiological endpoints [Time frame: Baseline]
- Clinical outcomes during follow-up [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clinic, University of Barcelona — Barcelona
Publications
- Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhyth PMID 36017572
- Arenal A, Avila P, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles FJ, Berruezo A. Substrate Ablation vs Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia. J Am Coll Cardiol. 2022 Apr 19;79(15):1441-1453. doi: 10.1016/j.jacc.2022.01.050. PMID 35422240
- Tung R, Xue Y, Chen M, Jiang C, Shatz DY, Besser SA, Hu H, Chung FP, Nakahara S, Kim YH, Satomi K, Shen L, Liang E, Liao H, Gu K, Jiang R, Jiang J, Hori Y, Choi JI, Ueda A, Komatsu Y, Kazawa S, Soejima K, Chen SA, Nogami A, Yao Y; PAUSE-SCD Investigators. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD PMID 35507499
- Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Saenz Morales LC, Santangeli P, Sapp JL, Sarkozy A, Soejima K, Stevenson WG, Tedrow UB, PMID 31075787
- Laan D, Hopman LHGA, Figueras I Ventura RM, Sore B, Allaart CP, Kemme MJB, Gotte MJW, Postema PG, Bhagirath P. Ventricular tachycardia substrate mapping with cardiac computed tomography and cardiac magnetic resonance imaging: Head-to-head comparison of two clinically available postprocessing platforms. Heart Rhythm. 2026 Mar;23(3):721-729. doi: 10.1016/j.hrthm.2025.09.028. Epub 2025 Sep 19. PMID 40976541
- Reventos-Presmanes J, Hernandez-Romero I, Pellicer-Sendra B, Guillen-Buisan E, Serrano-Campaner J, Invers-Rubio E, Regany-Closa M, Garre P, Borras R, Costafreda A, Arbelo E, Tolosana JM, Guasch E, Althoff TF, Guichard JB, Falzone PV, Vazquez-Calvo S, Ayauja E, Guillem MS, Porta-Sanchez A, Mont L, Climent AM, Roca-Luque I. Noninvasive assessment of the ventricular arrhythmogenic substrate using ele PMID 40683550
Identifiers
NCT: NCT07746336 · APOLO-VT