Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

NCT05617456 | Recruiting

• 1 other identifier: 20977
• Study Type: observational
• Target: 4,100
• Locations: 1 country
• Sites: 1

Brief Summary

ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected. The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 20 clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.

Conditions

Cardiac Arrhythmia; Atrial Fibrillation

Keywords

Catheter ablation; Arrhythmias; Atrial fibrillation; Mapping system; Single-shot ablation

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome of this study measures the baseline patient's characteristics (clinical history and drug therapy) and electro-anatomical variables derived from the ablation approach (e.g. evaluation of voltage and activation maps, lesion validation, procedural workflow) as potential predictors of documented atrial arrhythmias, that will be evaluated at 12 months. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for \>30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure

  12 months

Secondary Outcomes (11)

• Acute procedural success of AF ablation

  within 30 minutes after ablation procedure

• Number and percentage of patients with clinical atrial arrhythmia recurrences in the mid-term

  12 months

• Number and percentage of patients with clinical atrial arrhythmia recurrences in the long- and very long- term

  60 months

• Procedural ablation parameters

  Intraoperative

• Patient management parameters

  7 days after the procedure

Interventions

AF ablation PROCEDURE

Patients with standard indications to AF ablation

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 AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information

You may qualify if:

• Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
• Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
• Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
• Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
• Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
• Life expectancy ≤ 12 months per physician judgment.
• Unrecovered/unresolved Adverse Events from any previous invasive procedure;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
• Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
• AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause

Sponsors & Collaborators

• Giulio Zucchelli: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

RECRUITING

Related Publications (5)

• Moltrasio M, Iacopino S, Solimene F, Bianchi S, Schiavone M, Themistoclakis S, Rossillo A, Bertini M, Zirolia D, Volpicelli M, Zingarini G, Dello Russo A, Malacrida M, Zucchelli G, Tondo C. Termination of atrial arrhythmia and restoration of sinus rhythm during pulsed field ablation with a pentaspline catheter in patients with persistent atrial fibrillation. Europace. 2025 Jul 1;27(7):euaf144. doi: 10.1093/europace/euaf144.

  PMID: 40624924 DERIVED

• Dello Russo A, Tondo C, Bianchi S, Schillaci V, Iacopino S, Casella M, Rossillo A, Maggio R, Themistoclakis S, Bertini M, Russo M, Volpicelli M, Viola G, Rordorf R, Schiavone M, Valeri Y, Colella J, Rossi P, Tundo F, Zingarini G, De Simone A, Bianchini L, Di Vilio A, Compagnucci P, Malacrida M, Zucchelli G, Solimene F. Does Age Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation? J Am Heart Assoc. 2025 May 6;14(9):e037959. doi: 10.1161/JAHA.124.037959. Epub 2025 Apr 23.

  PMID: 40265595 DERIVED

• Bisignani A, Solimene F, Iacopino S, Polselli M, Dello Russo A, Tondo C, Rossillo A, Themistoclakis S, Maggio R, Russo M, Volpicelli M, Schillaci V, Schiavone M, Colella J, Casella M, Malacrida M, Zucchelli G, Bianchi S. Insight Into Early Recurrences After Pulsed-Field Ablation for Atrial Fibrillation: Results From a Multicenter Experience. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1323-1332. doi: 10.1111/jce.16670. Epub 2025 Apr 7.

  PMID: 40190033 DERIVED

• Bisignani A, Schiavone M, Solimene F, Dello Russo A, Filannino P, Magnocavallo M, Tondo C, Schillaci V, Casella M, Petretta A, Rossi P, Fassini G, Rossillo A, Maggio R, Themistoclakis S, Pandozi C, Polselli M, Tundo F, Arestia A, Compagnucci P, Valente Perrone A, Malacrida M, Iacopino S, Bianchi S. National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety. J Interv Card Electrophysiol. 2024 Dec;67(9):2127-2136. doi: 10.1007/s10840-024-01835-6. Epub 2024 May 30.

  PMID: 38814525 DERIVED

• Iacopino S, Colella J, Dini D, Mantovani L, Sorrenti PF, Malacrida M, Filannino P. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration. Europace. 2023 Aug 2;25(9):euad230. doi: 10.1093/europace/euad230.

  PMID: 37494101 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Giulio Zucchelli, MD, PhD

CONTACT

+393283687691; g.zucchelli@ao-pisa.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: November 15, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

IT (1)