Clinical trial NCT03793998: Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice.
Official title: Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice. The CHARISMA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmias
Keywords: Cardiac Catheter Ablation
Cardiac Arrhythmias
Mapping System
Lead sponsor: Azienda Ospedaliera Pugliese Ciaccio
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with arrhythmia recurrences
timeFrame: 12 months
Secondary outcomes:
measure: The percentage of acute procedural success of arrhythmias ablation
timeFrame: within 30 minutes after ablation procedure
measure: Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
timeFrame: within 30 minutes after ablation procedure
measure: Rate of new onset of different arrhythmias (from the primary one)
timeFrame: 12 months
measure: Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)
timeFrame: 36 months
measure: Overall procedure time
timeFrame: Intraoperative
measure: Rate of the adverse events associated with the primary ablation procedure
timeFrame: 12 months
measure: Estimate costs related to the use of health care resources
timeFrame: 60 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
Study officials:
affiliation: Azienda Ospedaliera Pugliese Ciaccio
name: Giampiero Maglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.