Atrial Flutter Ablation in a Real World Population

• Conditions: Atrial Flutter

• Registration Number: NCT02591875
• Lead Sponsor: Azienda Ospedaliera Pugliese Ciaccio

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient undergoing ablation of atrial flutter isthmus-dependent
• Patient able to sign an authorization to use and disclose health information or an Informed Consent.
• Patient available to attend scheduled follow-up visits at the center for at least 12 months

Exclusion Criteria

• Patient is participating in another clinical study that may have an impact on the study endpoints

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Complete Bidirectional Conduction Block	Time Frame: within 30 minutes after ablation procedure	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence of symptoms of AFL, measured as the proportion of patients reporting symptoms during follow-up	12 months	number of patients with symptoms of AFL during follow-up
Lesion's validation criteria	an average of 12 months following the ablation procedure	agreement between acute ablation success and long-term absence of AFL recurrence
Ablation procedure time	intraoperative	* RadioFrequency time; * ablation time; * Fluoroscopy time
Recurrence of AFL, measured as the proportion of patients with an episode longer than 30s documented at 24h Holter ECG recording during follow-up	12 months	number of patients with recurrence of AFL documented at ECG recording during follow-up
Adverse Events during Follow up	12 months
Acute adverse events	intraoperative

Trial Locations

Locations (4)

Fondazione Poliambulanza - Istituto Ospedaliero; 🇮🇹 Brescia, BS, Italy

Clinica Montevergine; 🇮🇹 Mercogliano, AV, Italy

Presidio Ospedaliero Policlinico Casilino; 🇮🇹 Roma, RM, Italy

Azienda Ospedaliera Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy