Treatment Based on High Precision Cardiac Mapping (APOLO-VT)
24. august 2026 oppdatert av: Ivo Roca, Hospital Clinic of Barcelona
Treatment Based on High Precision Cardiac Mapping: Advancing Personalized Outcomes Through Optimized Localization
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic, University of Barcelona
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Ta kontakt med:
- Ivo Roca-Luque, M.D., Ph.D.
- E-post: iroca@clinic.cat
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Ta kontakt med:
- Lluis Mont, M.D., Ph.D.
- E-post: lmont@clinic.cat
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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VT recurrence
Tidsramme: 12 months
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Recurrence of sustained ventricular tachycardia after the index ablation.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acute procedural outcomes
Tidsramme: Baseline
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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).
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Baseline
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Procedure complications
Tidsramme: Baseline
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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)
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Baseline
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Electrophysiological endpoints
Tidsramme: Baseline
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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.
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Baseline
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Clinical outcomes during follow-up
Tidsramme: 12 months
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Effect of the APOLO-VT ablation strategy on ICD therapies, heart failure hospitalization, and all-cause mortality during follow-up.
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
20. juli 2026
Først innsendt som oppfylte QC-kriteriene
31. juli 2026
Først lagt ut (Faktiske)
5. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- APOLO-VT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .