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Heart device data may unlock secrets of rare heart muscle disease

NCT ID NCT07688200

Knowledge-focused Sponsor: Policlinico Casilino ASL RMB Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study looks back at the medical records of 300 people with arrhythmogenic cardiomyopathy who have an implantable cardioverter-defibrillator (ICD) and have had dangerous heart rhythms. Researchers want to count how often ICD-related problems occur, such as lead failure or inappropriate shocks, and to describe the types of heart rhythm episodes recorded. The goal is to find patterns that could help doctors better manage this rare heart condition and improve device safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better predict and manage dangerous heart rhythms and ICD complications in people with arrhythmogenic cardiomyopathy.
What could go wrong
This is an observational study that looks back at past data, so it cannot prove cause and effect. Results may not apply to all patients or lead to immediate changes in treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

arrhythmogenic right ventricular cardiomyopathy cardiac arrest combat disorder impulse control disorder ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmogenic cardiomyopathy (ac, arvd/C) ICD Icd malfunction Icd shocks Ventricular arrhythmia Ventricular arrhythmias and cardiac arrest Ventricular fibrillation Ventricular tachycardia (VT)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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