Atrial Flutter Ablation in a Real World Population

Overview

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.

Full Title of Study: “Atrial Flutter Ablation in a Real World Population: A Multicenter Italian Registry (The LEONARDO Study)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Subjects With Complete Bidirectional Conduction Block
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliera Pugliese Ciaccio
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giampiero Maglia, Head of Electrophysiology and Cardiac Pacing – Azienda Ospedaliera Pugliese Ciaccio
  • Overall Contact(s)
    • Giampiero Maglia, MD, 0039 0963 531325, Clinical-leonardo@isis.it

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