Cardiac Arrhythmias
Conditions
Keywords
Cardiac Catheter Ablation, Cardiac Arrhythmias, Mapping System
Brief summary
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
Interventions
None listed
Sponsors
Azienda Ospedaliera Pugliese Ciaccio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are eligible for ablation procedure of atrial and ventricular arrhythmia; * Patients who are able to sign an authorization to use and disclose health information and capable of providing informed consent. * Patients who are willing and capable to attend scheduled follow-up visits at the clinical investigational center for at least 12 months
Exclusion criteria
* Patients who are currently enrolled in another clinical study that would directly interfere with the clinical practice of the investigational center
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with arrhythmia recurrences | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation | within 30 minutes after ablation procedure | This secondary outcome measures the baseline patient's characteristics (clinical history and drug therapy) as potential predictors of acute success |
| Rate of new onset of different arrhythmias (from the primary one) | 12 months | 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 |
| Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy) | 36 months | 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 |
| The percentage of acute procedural success of arrhythmias ablation | within 30 minutes after ablation procedure | 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. |
| Rate of the adverse events associated with the primary ablation procedure | 12 months | This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months |
| Estimate costs related to the use of health care resources | 60 months | 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 |
| Overall procedure time | Intraoperative | This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time |
Countries
Italy
Contacts
Primary ContactGiampiero Maglia, MD
Outcome results
None listed