An observational study in Arrhythmia, Cardiomyopathy, Dilated and Systolic Dysfunction, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence.
In recent decades, with advances in medical knowledge and technology, non-pharmacological therapies for arrhythmias have become increasingly popular. These fall into two broad categories: therapies aimed at electrostimulation and those aimed at ablation of arrhythmias.
The selection of patients eligible for these procedures is essential for the effectiveness of the therapy, the reduction of complications and the optimisation of resources.
Not all patients, even those selected according to guidelines, respond equally to the chosen therapy. Other patients, due to their clinical/ECG characteristics, do not have clear indications and remain in a borderline area where the class of evidence and/or recommendation of the guidelines is less stringent. Still others develop recurrences or complications during follow-up that require further intervention.
In this context, it is essential in the study of these patients not only to use standard instrumental examinations, such as echocardiograms, Holter ECGs and stress tests (simple and cardiopulmonary), but also and above all to use advanced imaging methods (STE, 3D echo, MRI, CT, PET-CT) and remote monitoring tools that integrate diagnostic algorithms managed by artificial intelligence.
In light of these considerations, our project consists of conducting an observational study that includes all patients with arrhythmias who are candidates for electrostimulation and/or ablation procedures at the Arrhythmology Unit and/or followed up at the Arrhythmology Clinic of our Polyclinic, in order to assess the clinical and/or imaging characteristics associated with a worse prognosis in this population, in terms of response to therapy and development of complications. Our main aim is to identify, within the above-mentioned population, the subgroups of responder patients versus non-responder patients, i.e. those with a worse prognosis , who deserve greater attention and more frequent follow-up.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 253 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Compared within Atrial Fibrillation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients who are candidates for electrophysiological and/or electrostimulation procedures
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
clinical and echocardiographic evaluation during hospitalization and at 6 months
analysis of pathophysiological mechanisms
analysis of pathophysiological mechanisms underlying the relationship between the electrical and mechanical components of myocardial cells and to identify possible prognostic markers useful in optimising the therapeutic process for patients.
Time frame: 6 months
relationship between arrhythmias and cardiac function
relationship between arrhythmias and cardiac function evaluated with speckle tracking echocardiography
Time frame: 6 months
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →