NCT05617456Recruiting
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study
Source: ClinicalTrials.gov · Last updated 15 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4100 (estimated)
- First submitted
- 4 Oct 2022
- Start date
- 1 Jan 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Giulio Zucchelli
- Diseases
- Atrial fibrillation
- NCT number
- NCT05617456
What you commit to
- Study type: Observational
- Planned participants: 4100
- From 1 Jan 2022 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
Related publications
- Machine learning prediction of outcome following pulsed-field atrial fibrillation ablation: patient selection and risk factors.Europace · 2026 · PMID 42134812
- Pulsed field ablation for atrial fibrillation in patients with heart failure: insight from the ATHENA registrys.Europace · 2026 · PMID 41910215
- 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 · PMID 41676924
This page is information, not medical advice. Discuss any trial with your doctor.