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

NCT03793998 | Unknown

• 1 other identifier: Protocollo n. 89 (17/04/2018)
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Arrhythmias

Keywords

Cardiac Catheter Ablation; Cardiac Arrhythmias; Mapping System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The percentage of acute procedural success of arrhythmias ablation

  within 30 minutes after ablation procedure

• Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation

  within 30 minutes after ablation procedure

• Rate of new onset of different arrhythmias (from the primary one)

  12 months

• Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)

  36 months

• Overall procedure time

  Intraoperative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who are currently enrolled in another clinical study that would directly interfere with the clinical practice of the investigational center

Sponsors & Collaborators

• Azienda Ospedaliera Pugliese Ciaccio: lead

Study Sites (1)

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, 88100, Italy

RECRUITING

Related Publications (12)

• Mantovan R, Bianchi S, Pelargonio G, Solimene F, Malacrida M, Carbone A, Anselmino M, Gallucci M, Segreti L, Galeazzi M, Bianco D, Giomi A, Mirizzi G, Rossi L, Zingarini G, Calvanese R, Allocca G, Ducceschi V, Dell'Era G, Bisignani A, Scacciavillani R, Schillaci V, Rivetti L, Bulian F. Ultra High-Density Mapping and Ablation of Localized Micro-Reentrant Tachycardias: Insight From the CHARISMA Registry. J Cardiovasc Electrophysiol. 2025 Apr;36(4):794-806. doi: 10.1111/jce.16563. Epub 2025 Jan 30.

  PMID: 39888109 DERIVED

• Schiavone M, Bianchi S, Malacrida M, Fassini G, Ricciolino R, Pecora D, Pelargonio G, Iacopino S, Ducceschi V, Maggio R, Bianchini L, La Greca C, Rossi P, Bencardino G, Moltrasio M, Di Belardino N, Pepi P, Rossi L, Santagostino M, Tondo C, De Simone A. Novel cryoballoon technology for atrial fibrillation ablation: Impact of pulmonary vein variant anatomy, cooling characteristics, and 1-year outcome from the CHARISMA registry. Heart Rhythm. 2025 May;22(5):1134-1141. doi: 10.1016/j.hrthm.2024.08.040. Epub 2024 Aug 22.

  PMID: 39181485 DERIVED

• Solimene F, Maggio R, De Sanctis V, Escande W, Malacrida M, Stabile G, Zakine C, Champ-Rigot L, Anselmino M, Ferraro A, Mantica M, Zucchelli G, Dell'Era G, Mascia G, Ricci Maga R, Pandozi C, Rossi P, Scaglione M, Zingarini G, Garnier F, Loricchio ML, Pelargonio G, Lepillier A. Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting. J Interv Card Electrophysiol. 2024 Dec;67(9):2137-2146. doi: 10.1007/s10840-024-01849-0. Epub 2024 Jul 8.

  PMID: 38972960 DERIVED

• Bianchi S, De Simone A, Iacopino S, Fassini G, Malacrida M, Rossi P, Stabile G, Petretta A, Tundo F, Cauti FM, Iuliano S, Filannino P, Moltrasio M, Morlacchi Bonfanti M, Pelargonio G, Pecora D, Ferraro A, Tondo C. Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry. Pacing Clin Electrophysiol. 2023 Nov;46(11):1302-1309. doi: 10.1111/pace.14839. Epub 2023 Oct 17.

  PMID: 37846769 DERIVED

• Lepillier A, Maggio R, De Sanctis V, Malacrida M, Stabile G, Zakine C, Champ-Rigot L, Anselmino M, Segreti L, Dell'Era G, Garnier F, Mascia G, Pandozi C, Dello Russo A, Scaglione M, Cosaro G, Ferraro A, Paziaud O, Maglia G, Solimene F. Insight into contact force local impedance technology for predicting effective pulmonary vein isolation. Front Cardiovasc Med. 2023 Jul 5;10:1169037. doi: 10.3389/fcvm.2023.1169037. eCollection 2023.

  PMID: 37476572 DERIVED

• Schillaci V, Arestia A, Maddaluno F, Shopova G, Agresta A, Salito A, Stabile G, Marano G, Bottaro G, Malacrida M, Solimene F. Combining contact force and local impedance to treat idiopathic premature ventricular contractions from the outflow tracts: impact of ablation strategy on outcomes. J Interv Card Electrophysiol. 2023 Dec;66(9):2011-2020. doi: 10.1007/s10840-023-01528-6. Epub 2023 Mar 24.

  PMID: 36964415 DERIVED

• Spera F, Narducci ML, Bencardino G, Perna F, Bisignani A, Pinnacchio G, Tondo C, Maggio R, Stabile G, Iacopino S, Tundo F, Ferraro A, De Simone A, Malacrida M, Pintus F, Crea F, Pelargonio G. Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation. Front Cardiovasc Med. 2022 Nov 9;9:985182. doi: 10.3389/fcvm.2022.985182. eCollection 2022.

  PMID: 36439999 DERIVED

• 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.

  PMID: 35524404 DERIVED

• 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.

  PMID: 35383979 DERIVED

• 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.

  PMID: 35322330 DERIVED

• 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.

  PMID: 34853986 DERIVED

• 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.

  PMID: 32766944 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giampiero Maglia, MD

  Azienda Ospedaliera Pugliese Ciaccio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giampiero Maglia, MD

CONTACT

0039 0963 531325; clinical-charisma@eleva-hosting.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Electrophysiology and Cardiac Pacing

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 4, 2019
• Study Start: May 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

IT (1)