Atrial Flutter Ablation in a Real World Population

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02591875
• Other study ID #: Protocollo n. 156 (06/11/2015)
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2015
• Last updated: October 18, 2016
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2016
• Source: Azienda Ospedaliera Pugliese Ciaccio
• Contact: Giampiero Maglia, MD
• Phone: 0039 0963 531325
• Email: Clinical-leonardo[@]isis.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Flutter

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza - Istituto Ospedaliero	Brescia	BS
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro
Italy	Clinica Montevergine	Mercogliano	AV
Italy	Presidio Ospedaliero Policlinico Casilino	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Pugliese Ciaccio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Ablation procedure time	RadioFrequency time; ablation time; Fluoroscopy time	intraoperative	No
Secondary	Acute adverse events		intraoperative	Yes
Secondary	Adverse Events during Follow up		12 months	Yes