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Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies (TRACE-ACM)

30. juni 2026 opdateret af: Leonardo Calò, MD, Policlinico Casilino ASL RMB

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study

TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias. The study aims to describe the prevalence and type of ICD-related complications, characterize ventricular arrhythmias documented by ICD electrograms and/or ECG recordings, and explore associations between clinical, device-related, and treatment-related factors and arrhythmic outcomes.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Patients with arrhythmogenic cardiomyopathy will be identified at participating centers with expertise in the diagnosis and management of arrhythmogenic cardiomyopathies. De-identified retrospective data will be collected, including demographics, arrhythmogenic cardiomyopathy phenotype, genetic data, ICD type and indication, clinical follow-up, ICD therapies, antiarrhythmic and heart failure therapies, catheter ablation, and ECG/ICD electrogram documentation of ventricular tachyarrhythmias.

ICD-related complications will include implant-related complications such as hematoma, perforation, pneumothorax, upper-limb deep vein thrombosis, lead failure, and infection, as well as non-implant-related complications such as inappropriate shocks. Ventricular arrhythmias will be classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation, or transition patterns between these arrhythmia types. When available, arrhythmia initiation will be analyzed using pre-specified ECG/EGM criteria including the origin of the beats preceding arrhythmia onset, R1-R2 and R2-R3 intervals, pause dependency, coupling interval, and prematurity index.

The study will also describe atrial arrhythmias and medical, interventional, and device-based therapies adopted in this population, and will explore their relationship with ventricular arrhythmia recurrences and ICD interventions.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population includes patients with arrhythmogenic cardiomyopathy followed at participating expert centers who underwent implantable cardioverter-defibrillator implantation and had documented sustained ventricular tachyarrhythmias. Eligible patients may have right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy. Patients must have periodic clinical and ICD follow-up, with arrhythmia onset available from ICD electrograms and/or ECG recordings suitable for centralized analysis. Patients with significant coronary artery disease, primary valvular or congenital heart disease, infiltrative or inflammatory cardiomyopathies, or prior cardiotoxic therapy exposure are excluded.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of arrhythmogenic cardiomyopathy, including right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy.
  • ICD implantation.
  • Documented sustained ventricular tachyarrhythmia, including polymorphic ventricular tachycardia, ventricular fibrillation, or monomorphic ventricular tachycardia.
  • Periodic clinical and ICD follow-up.
  • Arrhythmia onset available from ICD electrograms and/or ECG recordings.
  • ECG/EGM tracings available for analysis by the steering ECG committee.

Exclusion Criteria:

  • Incomplete ICD data or incomplete ICD follow-up.
  • Significant coronary artery disease, defined as coronary plaque greater than 50% at coronary angiography or coronary computed tomography angiography.
  • Primary valvular heart disease or congenital heart disease.
  • Infiltrative or inflammatory cardiomyopathies, including sarcoidosis or amyloidosis.
  • Previous exposure to therapies associated with cardiac toxicity, including chemotherapy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients with arrhythmogenic cardiomyopathy and ICD
Patients with arrhythmogenic cardiomyopathy, ICD implantation, and documented sustained ventricular tachyarrhythmias, with available ICD electrograms and/or ECG recordings suitable for analysis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with ICD-related complications
Tidsramme: through study completion, an average of 1 year
Number of participants experiencing at least one ICD-related complication during follow-up, including implant-related complications such as hematoma, perforation, pneumothorax, upper-limb deep vein thrombosis, lead failure, and infection, and non-implant-related complications such as inappropriate shocks.
through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of ventricular tachyarrhythmia episodes by arrhythmia type
Tidsramme: through study completion, an average of 1 year
Number of documented ventricular tachyarrhythmia episodes classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, ventricular fibrillation, or transition patterns between arrhythmia types.
through study completion, an average of 1 year
Number of ventricular arrhythmia episodes classified by initiation pattern
Tidsramme: through study completion, an average of 1 year
Number of analyzable ventricular arrhythmia episodes classified according to pre-specified ECG or EGM initiation patterns, including type A and type B initiation, ventricular origin of preceding beats, pause dependency, coupling interval, and prematurity index.
through study completion, an average of 1 year
Number of ventricular arrhythmia recurrences
Tidsramme: through study completion, an average of 1 year
Number of ventricular arrhythmia recurrences documented during follow-up after ICD implantation. Treatment exposure, including antiarrhythmic drug therapy, heart failure therapy, catheter ablation, and ICD programming strategy, will be recorded as baseline or follow-up clinical variables.
through study completion, an average of 1 year
Number of ventricular arrhythmia episodes by autonomic pattern
Tidsramme: through study completion, an average of 1 year
Number of ventricular arrhythmia episodes classified according to available clinical circumstances suggestive of adrenergic or vagal predominance.
through study completion, an average of 1 year
Number of appropriate ICD interventions
Tidsramme: through study completion, an average of 1 year
Number of appropriate ICD interventions, including antitachycardia pacing and appropriate ICD shocks, delivered for ventricular arrhythmias during follow-up.
through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Policlinico Casilino ASL RMB

Efterforskere

  • Studieleder: Luca Barca, MD, Policlinico Casilino, Rome
  • Studieleder: Cinzia Crescenzi, MD, Policlinico Casilino, Rome
  • Studieleder: Kristian Galanti, MD, Policlinico Casilino, Rome
  • Studieleder: Alessandro Nudi, MD, Policlinico Casilino, Rome

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 1. Corrado D, Anastasakis A, Basso C, et al. Proposed diagnostic criteria for arrhythmogenic cardiomyopathy: European Task Force consensus report. Int J Cardiol. 2024;395:131447. doi:10.1016/j.ijcard.2023.131447. 2. Zeppenfeld K, Tfelt-Hansen J, de Riva M, et al. 2022 ESC Guidelines for ventricular arrhythmias and prevention of sudden cardiac death. Eur Heart J. 2022;43:3997-4126. doi:10.1093/eurheartj/ehac262. 3. Gasperetti A, James CA, Duru F, van Tintelen P, Calkins H. Arrhythmogenic right ventricular cardiomyopathy. Eur Heart J. 2026;ehag297. doi:10.1093/eurheartj/ehag297. 4. Arbelo E, Protonotarios A, Gimeno JR, et al. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023;44:3503-3626. 5. Towbin JA, McKenna WJ, Abrams DJ, et al. 2019 HRS expert consensus statement on arrhythmogenic cardiomyopathy. Heart Rhythm. 2019;16:e301-e372. doi:10.1016/j.hrthm.2019.05.007. 6. Christensen AH, Platonov PG, Svensson A, et al. Complications of implantable cardioverter-defibrillator treatment in arrhythmogenic right ventricular cardiomyopathy. Europace. 2022;24:306-312. 7. Migliore F, Pittorru R, De Lazzari M, et al. Third-generation subcutaneous ICD and intermuscular two-incision implantation in arrhythmogenic cardiomyopathy: 3-year follow-up. Int J Cardiol. 2023;382:33-39. 8. Belhassen B, Conte G, Steinberg C, et al. Mode and characteristics of arrhythmia initiation in idiopathic ventricular fibrillation: A THESIS substudy. JACC Clin Electrophysiol. 2024;10:1794-1809. 9. Gaine S, Rolland T, Asatryan B, et al. Long-term follow-up data on flecainide use as an antiarrhythmic in arrhythmogenic right ventricular cardiomyopathy. JACC Clin Electrophysiol. 2025;11:1159-1170. doi:10.1016/j.jacep.2025.02.023.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRACE-ACM-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared because the study includes retrospective clinical, device, ECG/EGM, and genetic data subject to privacy, ethical, and institutional restrictions. Aggregate study results may be shared through scientific presentations and peer-reviewed publications.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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