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Cardiac ArrhythmiasCHARISMANCT03793998

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

An observational study of Cardiac Arrhythmias, run by Azienda Ospedaliera Pugliese Ciaccio at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiac Arrhythmias
How many people
2,000 participants
Where
1 siteItaly
Study dates
1 May 2018to Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Giampiero Maglia, MD contact

0039 0963 531325

clinical-charisma@eleva-hosting.it

Italy1 site, 1 recruiting

  • Azienda Ospedaliera Pugliese-Ciaccio

    Catanzaro, 88100

    Giampiero Maglia, MD

    Giampiero Maglia, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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

Keywords
Cardiac Catheter Ablation, Cardiac Arrhythmias, Mapping System
Medical subject headings
Arrhythmias, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (7)

  1. 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.

    Measured: within 30 minutes after ablation procedure

  2. 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

    Measured: within 30 minutes after ablation procedure

  3. 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

    Measured: 12 months

  4. 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

    Measured: 36 months

  5. Overall procedure time

    This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time

    Measured: Intraoperative

  6. 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

    Measured: 12 months

  7. 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

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start1 May 2018
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793998
Sponsor's protocol ID
Protocollo n. 89 (17/04/2018)
Acronym
CHARISMA
Status last verified
Jan 2019
First submitted
29 Nov 2018
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No

Publications

  • Ribatti V, Dello Russo A, Riva S, Malacrida M, Bianchi S, Solimene F, Iacopino S, De Simone A, Rossillo A, Pelargonio G, Zucchelli G, Maggio R, Russo M, Pecora D, Bertini M, Bandino S, Volpicelli M, Compagnucci P, De Sanctis V, Anselmino M, Rordorf R, Zingarini G, Rovaris G, Agus E, Themistoclakis S, Mitacchione G, Mea R, Valeri Y, Tondo C, Casella M. De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy. J Am Heart Assoc. 2026 Mar 3;15(5):e041873. doi: 10.1161/JAHA.125.041873. Epub 2026 Feb 12.

    PubMed 41676924

  • 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.

    PubMed 39888109

  • 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.

    PubMed 39181485

  • 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.

    PubMed 38972960

  • 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.

    PubMed 37846769

  • 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.

    PubMed 37476572

  • 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.

    PubMed 36964415

  • 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.

    PubMed 36439999

  • 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.

    PubMed 35524404

  • 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.

    PubMed 35383979

  • 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.

    PubMed 35322330

  • 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.

    PubMed 34853986

  • 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.

    PubMed 32766944

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrhythmias, run by Azienda Ospedaliera Pugliese Ciaccio at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giampiero Maglia, MD (0039 0963 531325, clinical-charisma@eleva-hosting.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with arrhythmia recurrences (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793998, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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