RecruitingNCT05617456

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study


Sponsor

Giulio Zucchelli

Enrollment

4,100 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on outcomes from advanced ablation technologies used to treat atrial fibrillation (an irregular heartbeat), to understand how well these newer techniques work in routine clinical practice. **You may be eligible if...** - You are 18 or older and have atrial fibrillation that your doctor recommends treating with a catheter ablation procedure - You are willing and able to attend all required follow-up visits - You are able to provide informed consent **You may NOT be eligible if...** - You are already enrolled in another study that would interfere with this one - You are unwilling to sign consent forms or cannot attend follow-up visits - Your life expectancy is 12 months or less - You are pregnant or planning to become pregnant during the study - You have a blood clot in your heart's upper left chamber (within 4 weeks of the procedure) - Your atrial fibrillation is caused by a reversible condition like thyroid disease or electrolyte imbalance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAF ablation

Patients with standard indications to AF ablation


Locations(1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

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NCT05617456


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