An observational study in Cardiac Arrhythmias, sponsored by Azienda Ospedaliera Pugliese Ciaccio. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Azienda Ospedaliera Pugliese Ciaccio · Observational
The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia will be enrolled.
Patients can be treated with any market released catheter for ablation and diagnostic examination. The decision to perform the ablation will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. The study has been designed to describe the Italian clinical practice in relation to the ablation approach of different kind of arrhythmias. In particular, the investigators will analyze the percentage of acute and long-term success in clinical practice, predictors of arrhythmias recurrence and they will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Azienda Ospedaliera Pugliese Ciaccio is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients, clinically indicated for arrhythmias ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information
Exclusion Criteria:
Percentage of patients with arrhythmia recurrences
The primary outcome measure of this study is to estimate, after 12-months from the procedure, the percentage of patients with documented arrhythmia recurrences, recognized with the registration of at least 30 seconds of the same arrhythmias with 24h Holter ECG
Time frame: 12 months
The percentage of acute procedural success of arrhythmias ablation
This secondary outcome measures the percentage of acute procedural success. The acute success of the arrhythmias ablation is verified by; the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.
Time frame: within 30 minutes after ablation procedure
Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
This secondary outcome measures the baseline patient's characteristics (clinical history and drug therapy) as potential predictors of acute success
Time frame: within 30 minutes after ablation procedure
Rate of new onset of different arrhythmias (from the primary one)
This secondary outcome measures the rate of new onset of any kind of different arrhythmia (from the primary one) related to the primary ablation procedure
Time frame: 12 months
Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)
This secondary outcome measure of this study is to evaluate baseline patient's characteristics as potential predictors of primary arrhythmia recurrences, that will be evaluated at 12 months and 36 months follow up
Time frame: 36 months
Overall procedure time
This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time
Time frame: Intraoperative
Rate of the adverse events associated with the primary ablation procedure
This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months
Time frame: 12 months
Estimate costs related to the use of health care resources
This secondary outcome measures the resource consumption and the associated costs in term of ablation procedures, follow-up, management of complication and health care resources utilization
Time frame: 60 months
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Pugliese Ciaccio