Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

Recruiting now

Conditions studied: Cardiac Arrhythmia, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05617456

Run by

Giulio Zucchelli

People needed

4100

Starts

2022-01-01

Expected to finish

2029-01-01

Last updated by the study team

2022-11-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (enrolling)

Full record on ClinicalTrials.gov

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