Arrhythmogenic Cardiomyopathy (AC, ARVD/C)TRACE-ACMNCT07688200
Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies
An observational study of Arrhythmogenic Cardiomyopathy (AC, ARVD/C) and Ventricular Tachycardia (VT), run by Policlinico Casilino ASL RMB.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD, ICD Malfunction, ICD SHOCKS
- Keywords
- Implantable cardioverter-defibrillator, ICD complications, Arrhythmogenic cardiomyopathy, Monomorphic ventricular tachycardia, Polymorphic ventricular tachycardia, Ventricular fibrillation, ICD electrograms, Arrhythmic storm, Pause-dependent arrhythmia initiation, Catheter ablation, Antiarrhythmic drugs
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia, Tachycardia, Ventricular, Ventricular Fibrillation, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ICD-related complications
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Number of ventricular tachyarrhythmia episodes by arrhythmia type
Number of documented ventricular tachyarrhythmia episodes classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, ventricular fibrillation, or transition patterns between arrhythmia types.
Measured: through study completion, an average of 1 year
Number of ventricular arrhythmia episodes classified by initiation pattern
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.
Measured: through study completion, an average of 1 year
Number of ventricular arrhythmia recurrences
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.
Measured: through study completion, an average of 1 year
Number of ventricular arrhythmia episodes by autonomic pattern
Number of ventricular arrhythmia episodes classified according to available clinical circumstances suggestive of adrenergic or vagal predominance.
Measured: through study completion, an average of 1 year
Number of appropriate ICD interventions
Number of appropriate ICD interventions, including antitachycardia pacing and appropriate ICD shocks, delivered for ventricular arrhythmias during follow-up.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmogenic Cardiomyopathy (AC, ARVD/C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Casilino ASL RMB
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Calò, MD, Policlinico Casilino ASL RMB
- Investigators
- Luca Barca, MD, Study director, Policlinico Casilino, RomeCinzia Crescenzi, MD, Study director, Policlinico Casilino, RomeKristian Galanti, MD, Study director, Policlinico Casilino, RomeAlessandro Nudi, MD, Study director, Policlinico Casilino, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688200
- Sponsor's protocol ID
- TRACE-ACM-001
- Acronym
- TRACE-ACM
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07688200
- Acronym / sponsor ID
- TRACE-ACM / TRACE-ACM-001
- Conditions
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD, ICD Malfunction, ICD SHOCKS
- Keywords
- Implantable cardioverter-defibrillator, ICD complications, Arrhythmogenic cardiomyopathy, Monomorphic ventricular tachycardia, Polymorphic ventricular tachycardia, Ventricular fibrillation, ICD electrograms, Arrhythmic storm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Policlinico Casilino ASL RMBUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with ICD-related complications
Time frame: 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.
5 secondary outcomes
Number of ventricular tachyarrhythmia episodes by arrhythmia type
Time frame: through study completion, an average of 1 year
Number of ventricular arrhythmia episodes classified by initiation pattern
Time frame: through study completion, an average of 1 year
Number of ventricular arrhythmia recurrences
Time frame: through study completion, an average of 1 year
Number of ventricular arrhythmia episodes by autonomic pattern
Time frame: through study completion, an average of 1 year
Number of appropriate ICD interventions
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication1. 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Barca, MD study director
Policlinico Casilino, Rome
Cinzia Crescenzi, MD study director
Policlinico Casilino, Rome
Kristian Galanti, MD study director
Policlinico Casilino, Rome
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmogenic Cardiomyopathy (AC, ARVD/C) and Ventricular Tachycardia (VT), run by Policlinico Casilino ASL RMB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Calò, MD (+39 3388589677, leonardocalo.doc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ICD-related complications (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07688200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.