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Taking people in ItalyNo phase

Observes patients with atrial fibrillation receiving ablation in routine care

Follows patients with atrial fibrillation who receive ablation as part of standard care.

Key facts

Who runs it
Giulio Zucchelli
Where
Pisa, ItalySee the site
Trial code
Registry title
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Status
Recruiting
People taking part
4,100 people, planned
Started
1 Jan 2022
Expected to end
Jan 2029
Type of study
Observational
Treatments tested
  • AF ablation
Record updated
15 November 2022

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have an indication for a catheter ablation procedure to treat atrial fibrillation. They will be followed for 12 months after the procedure.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Atrial fibrillation with an indication for an ablation procedure, according to current guidelines and the doctor's judgement.
Earlier treatment
Cannot join if adverse events from an earlier invasive procedure have not recovered or resolved.

Main reasons for not taking part

  • Life expectancy of 12 months or less, in the doctor's judgement
  • Left atrial blood clot on imaging within 4 weeks before the procedure
  • Atrial fibrillation caused by an electrolyte imbalance, thyroid disease or another reversible non-heart cause
  • Women who are or plan to become pregnant during the study
  • Enrolled in another investigational study that would interfere with this one

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause
  • 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

Where in Italy

  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyContact: Giulio ZucchelliTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

Treatments tested

  • AF ablation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study
Plain-language title
Observes patients with atrial fibrillation receiving ablation in routine careGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
15 November 2022