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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrhythmias

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Giampiero Maglia, MD; Phone Number: 0039 0963 531325; Email: clinical-charisma@eleva-hosting.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Azienda Ospedaliera Pugliese-Ciaccio
    • Contact: Giampiero Maglia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Overall procedure time	This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time	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	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	60 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Pugliese Ciaccio
• Investigators: Principal Investigator: Giampiero Maglia, MD, Azienda Ospedaliera Pugliese Ciaccio

Publications and helpful links

General Publications

• Solimene F, Stabile G, Segreti L, Malacrida M, Schillaci V, Rossi P, Bongiorni MG, Shopova G, Cauti FM, Zucchelli G, Arestia A, Bianchi S, Di Cori A, Maddaluno F, De Simone A, Garcia-Bolao I. Targeted ablation of residual pulmonary vein potentials in atrial fibrillation ablation through ultra-high-density mapping: Insights from the CHARISMA registry. J Cardiovasc Electrophysiol. 2022 Jul;33(7):1414-1424. doi: 10.1111/jce.15527. Epub 2022 Jun 1.
• Ducceschi V, Zingarini G, Nigro G, Brasca FMA, Malacrida M, Carbone A, Lavalle C, Maglia G, Infusino T, Aloia A, Nicolis D, Auricchio C, Uccello A, Notaristefano F, Rago A, Botto GL, Esposito L. Optimized radiofrequency lesions through local impedance guidance for effective CTI ablation in right atrial flutter. Pacing Clin Electrophysiol. 2022 May;45(5):612-618. doi: 10.1111/pace.14482. Epub 2022 Apr 22.
• Solimene F, De Sanctis V, Maggio R, Malacrida M, Segreti L, Anselmino M, Schillaci V, Mantica M, Scaglione M, Dello Russo A, Cauti FM, Zingarini G, Pandozi C, Cavaiani M, Ferraro A, Maglia G, Stabile G. When local impedance meets contact force: preliminary experience from the CHARISMA registry. J Interv Card Electrophysiol. 2022 Apr;63(3):749-758. doi: 10.1007/s10840-022-01163-7. Epub 2022 Mar 24.
• Iacopino S, Stabile G, Fassini G, De Simone A, Petretta A, Moltrasio M, La Rocca V, Placentino F, Riva S, Pesce F, Rossi P, Pelargonio G, Iuliano A, Tundo F, Colella J, Tondo C. Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry. J Interv Card Electrophysiol. 2022 Sep;64(3):641-648. doi: 10.1007/s10840-021-01063-2. Epub 2021 Dec 2.
• Pandozi C, Lavalle C, Bongiorni MG, Catalano A, Pelargonio G, Russo M, Piro A, Carbone A, Narducci ML, Galeazzi M, Ficili S, Piccolo F, Maddaluno F, Malacrida M, Colivicchi F, Segreti L. High-density mapping of Koch's triangle during sinus rhythm and typical AV nodal reentrant tachycardia: new insight. J Interv Card Electrophysiol. 2021 Sep;61(3):487-497. doi: 10.1007/s10840-020-00841-8. Epub 2020 Aug 6.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac Arrhythmias; Cardiac Catheter Ablation; Mapping System
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Protocollo n. 89 (17/04/2018)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No