What is this study trying to find out about atrial fibrillation?

This study aims to evaluate patients undergoing atrial fibrillation ablation to identify clinical and procedural factors that predict success in preventing arrhythmia recurrence over 12 months. It helps understand which patients benefit most from ablation. The research is sponsored by Giulio Zucchelli and collects detailed real-world data over time.

Who may be eligible for this atrial fibrillation clinical trial?

Adults aged 18 years or older with an indication for atrial fibrillation ablation according to guidelines or physician judgment may be eligible. Both men and women can participate, except those who are pregnant or planning pregnancy. Participants must be willing to provide consent and complete follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this atrial fibrillation clinical trial?

Study-related care, including the ablation procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly when considering involvement.

Actively Recruiting

All Genders

ID05617456

Advanced Technologies For Successful Ablation of Atrial Fibrillation in Clinical Practice ATHENA Study

Led by Giulio Zucchelli · Updated on 2022-11-15

4100

Participants Needed

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Atrial fibrillation AF is the most common heart rhythm disorder worldwide, affecting about 3 of adults and expected to increase due to longer lifespans and more diagnoses. This study aims to prospectively evaluate a large group of patients undergoing AF ablation to identify clinical and procedural factors that predict success in preventing arrhythmia recurrence over the medium to long term. The main goal is to determine which parameters best predict freedom from clinical atrial arrhythmias 12 months after the procedure. Patients with indications for AF ablation will receive treatment following standard care at participating centers. The study collects data on procedural success immediately after ablation and tracks patients for 12 months to monitor for arrhythmia recurrence, other atrial arrhythmias, and any adverse events. The study will also assess patient-reported outcomes, ECG changes before and after ablation, and healthcare resource use. This observational study enrolls consecutive patients meeting eligibility criteria without altering their treatment plan. Participants will be followed for 12 months after their ablation procedure, with data collected on clinical history, drug therapy, arrhythmia recurrences, adverse events, and patient symptoms. Evaluations include acute procedural success, ECG monitoring, and questionnaires on quality of life and symptom severity. Researchers will analyze these data to identify factors associated with long-term success and safety of AF ablation. This study provides real-world insights into the management and outcomes of patients undergoing AF ablation over time.

CONDITIONS

Brief Title

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Patients with an indication for atrial fibrillation ablation based on current international and local guidelines or physician discretion
Patients willing and able to provide informed consent and participate in all testing at an approved clinical center
Patients aged 18 years or older and legally able to give informed consent

You will not qualify if you...

Patients enrolled in another investigational study or registry that interferes with this study, except mandatory governmental or purely observational registries
Patients unwilling or unable to sign authorization for use of health information or informed consent
Patients unavailable or unwilling to complete follow-up visits and examinations during the study
Patients with a life expectancy of 12 months or less based on physician judgment
Patients with unresolved adverse events from previous invasive procedures
Women of childbearing potential who are or plan to become pregnant during the study
Patients with left atrial thrombus detected within 4 weeks before the ablation procedure
Patients with atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible non-cardiac causes

Research Team

Giulio Zucchelli, MD, PhD

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