The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. The decision to perform the ablation of AFL will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. Patient time commitment for the study is approximately 12 months.The study has been designed to describe the italian clinical practice in relation to the approach of AFL ablation. In particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.
Catheter ablation of Atrial Flutter has become an accepted alternative to pharmacologic therapy.The current guidelines recommend the catheter ablation at the first episode of AFL (Class IIa) or in any case of recurrent episodes of AFL (Class I). Recent studies have already demonstrated a high degree of procedural efficacy (higher than 90%). However, there are still two main areas of investigation. First, what is the best method to obtain an effective lesion. Second, what is the most reliable method to validate the procedure success.The present study is aimed at investigating these aspects in the current Italian clinical practice.
Study Type
OBSERVATIONAL
Enrollment
1,000
Clinica Montevergine
Mercogliano, AV, Italy
RECRUITINGFondazione Poliambulanza - Istituto Ospedaliero
Brescia, BS, Italy
RECRUITINGPresidio Ospedaliero Policlinico Casilino
Roma, RM, Italy
RECRUITINGAzienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy
RECRUITINGPercentage of Subjects With Complete Bidirectional Conduction Block
Acute success is defined as the confirmation of complete bidirectional conduction block across the cavo-tricuspid isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Time frame: Time Frame: within 30 minutes after ablation procedure
Recurrence of symptoms of AFL, measured as the proportion of patients reporting symptoms during follow-up
number of patients with symptoms of AFL during follow-up
Time frame: 12 months
Recurrence of AFL, measured as the proportion of patients with an episode longer than 30s documented at 24h Holter ECG recording during follow-up
number of patients with recurrence of AFL documented at ECG recording during follow-up
Time frame: 12 months
Lesion's validation criteria
agreement between acute ablation success and long-term absence of AFL recurrence
Time frame: an average of 12 months following the ablation procedure
Ablation procedure time
* RadioFrequency time; * ablation time; * Fluoroscopy time
Time frame: intraoperative
Acute adverse events
Time frame: intraoperative
Adverse Events during Follow up
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.