Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice. (CHARISMA)

Azienda Ospedaliera Pugliese Ciaccio

Status: Unknown

Conditions: Cardiac Arrhythmias

Study type: Observational

Funder types: Other

Identifiers

NCT03793998

Protocollo n. 89 (17/04/2018)

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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