Treatment Based on High Precision Cardiac Mapping

NCT07746336 | Recruiting Phase 4

• 1 other identifier: APOLO-VT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• VT recurrence

  Recurrence of sustained ventricular tachycardia after the index ablation.

  12 months

Secondary Outcomes (4)

• Acute procedural outcomes

  Baseline

• Procedure complications

  Baseline

• Electrophysiological endpoints

  Baseline

• Clinical outcomes during follow-up

  12 months

Study Arms (1)

Ablation strategy

EXPERIMENTAL

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.

Device: ACORYS Mapping System

Interventions

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.

Ablation strategy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (6)

• 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 arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

• 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 BACKGROUND

• 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 Randomized Trial. Circulation. 2022 Jun 21;145(25):1839-1849. doi: 10.1161/CIRCULATIONAHA.122.060039. Epub 2022 May 4.

  PMID: 35507499 BACKGROUND

• 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, Tzou WS, Varma N, Zeppenfeld K; ESC Scientific Document Group. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Europace. 2019 Aug 1;21(8):1143-1144. doi: 10.1093/europace/euz132.

  PMID: 31075787 BACKGROUND

• 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 BACKGROUND

• 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 electrocardiographic imaging during sinus rhythm: The NIAVAS study. Heart Rhythm. 2026 Feb;23(2):249-263. doi: 10.1016/j.hrthm.2025.07.020. Epub 2025 Jul 17.

  PMID: 40683550 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Section. Cardiovascular Institute.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 5, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)