Atrial Flutter Ablation in a Real World Population

Atrial Flutter Ablation in a Real World Population: A Multicenter Italian Registry (The LEONARDO Study)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Flutter

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Azienda Ospedaliera Pugliese-Ciaccio
  • AV
    • Mercogliano, AV, Italy, 83024
      • Recruiting
      • Clinica Montevergine
      • Contact: Francesco Solimene, MD
      • Principal Investigator: Francesco Solimene, MD
  • BS
    • Brescia, BS, Italy, 25124
      • Recruiting
      • Fondazione Poliambulanza - Istituto Ospedaliero
      • Contact: Domenico Pecora, MD
      • Principal Investigator: Domenico Pecora, MD
      • Sub-Investigator: Carmelo La Greca, MD
  • RM
    • Roma, RM, Italy, 00172
      • Recruiting
      • Presidio Ospedaliero Policlinico Casilino
      • Contact: Domenico Grieco, MD
      • Principal Investigator: Leonardo Calò, Prof.
      • Sub-Investigator: Domenico Grieco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients, clinically indicated for an atrial flutter ablation, will be enrolled after signing of an informed consent form and an authorization to use and disclose health information.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage 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: within 30 minutes after ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months
Lesion's validation criteria	agreement between acute ablation success and long-term absence of AFL recurrence	an average of 12 months following the ablation procedure
Ablation procedure time	RadioFrequency time;; ablation time;; Fluoroscopy time	intraoperative
Acute adverse events		intraoperative
Adverse Events during Follow up		12 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Pugliese Ciaccio

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac Arrhythmias; Atrial Flutter; Cardiac Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: Protocollo n. 156 (06/11/2015)