Evaluating new technologies for successful atrial fibrillation ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Azienda Ospedaliero Universitaria Pisana
  Pisa, Italy Recruiting

Study contacts

• Study coordinator: Giulio Zucchelli, MD, PhD
• Email: g.zucchelli@ao-pisa.toscana.it
• Phone: +393283687691

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

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• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.