Clinical trial NCT02591875: Atrial Flutter Ablation in a Real World Population
Official title: Atrial Flutter Ablation in a Real World Population: A Multicenter Italian Registry (The LEONARDO Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Flutter
Keywords: Cardiac Catheter Ablation
Cardiac Arrhythmias
Atrial Flutter
Lead sponsor: Azienda Ospedaliera Pugliese Ciaccio
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With Complete Bidirectional Conduction Block
timeFrame: Time Frame: within 30 minutes after ablation procedure
Secondary outcomes:
measure: Recurrence of symptoms of AFL, measured as the proportion of patients reporting symptoms during follow-up
timeFrame: 12 months
measure: Recurrence of AFL, measured as the proportion of patients with an episode longer than 30s documented at 24h Holter ECG recording during follow-up
timeFrame: 12 months
measure: Lesion's validation criteria
timeFrame: an average of 12 months following the ablation procedure
measure: Ablation procedure time
timeFrame: intraoperative
measure: Acute adverse events
timeFrame: intraoperative
measure: Adverse Events during Follow up
timeFrame: 12 months
Other outcomes:
Locations:
city: Mercogliano
country: Italy
facility: Clinica Montevergine
state: AV
city: Brescia
country: Italy
facility: Fondazione Poliambulanza - Istituto Ospedaliero
state: BS
city: Roma
country: Italy
facility: Presidio Ospedaliero Policlinico Casilino
state: RM
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
Study officials:
References: