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

Cardiac Arrhythmias Clinical Trial

— CHARISMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793998
• Other study ID #: Protocollo n. 89 (17/04/2018)
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: January 2024

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliera Pugliese Ciaccio
• Contact: Giampiero Maglia, MD
• Phone: 0039 0963 531325
• Email: clinical-charisma[@]eleva-hosting.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Pugliese Ciaccio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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.	within 30 minutes after ablation procedure
Secondary	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	within 30 minutes after ablation procedure
Secondary	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	12 months
Secondary	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	36 months
Secondary	Overall procedure time	This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time	Intraoperative
Secondary	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	12 months
Secondary	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	60 months