Evaluating new technologies for successful atrial fibrillation ablation
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study
This study is testing how well a common heart procedure called catheter ablation works for people with atrial fibrillation over a year to see if it helps keep their heart rhythm steady.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4100 (estimated) |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana Academic / other |
| Locations | 1 site (Pisa) |
| Trial ID | NCT05617456 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of catheter ablation for atrial fibrillation (AF) in a large population over a 12-month follow-up period. It will collect data on clinical outcomes, including recurrence of AF and other atrial arrhythmias, as well as adverse events. The study will analyze up to 20 clinical and procedural parameters to identify predictors of long-term success in AF ablation. Patients will be treated according to standard care protocols at participating centers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with an indication for AF ablation according to current guidelines.
Not a fit: Patients currently enrolled in other investigational studies that may interfere with this study will not benefit.
Why it matters
Potential benefit: If successful, this study could improve the long-term outcomes of patients undergoing ablation for atrial fibrillation.
How similar studies have performed: Previous studies have shown success with catheter ablation techniques for atrial fibrillation, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Pisa
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: Giulio Zucchelli, MD, PhD
- Email: g.zucchelli@ao-pisa.toscana.it
- Phone: +393283687691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.