Atrial Flutter Ablation in a Real World Population

Status Recruiting

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Atrial Flutter

Clinical Trial Details

NCT number	NCT02591875
Study type	Observational
Source	Azienda Ospedaliera Pugliese Ciaccio
Contact	Giampiero Maglia, MD
Phone	0039 0963 531325
Email	Clinical-leonardo@isis.it
Status	Recruiting
Phase	N/A
Start date	October 2015
Completion date	December 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Terminated	`NCT02317029` - Comparison of Oxygen Interventions and Defibrillator Efficiency	N/A
Recruiting	`NCT01563848` - Cryoablation in Patients With Atrial Flutter	Phase 2
Completed	`NCT01229254` - Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter	Phase 2
Completed	`NCT00839657` - Clarification of Optimal Anticoagulation Through Genetics	Phase 3
Completed	`NCT02065388` - Pharmacogenetic Dosing of Warfarin	Phase 3
Completed	`NCT00232232` - Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia	Phase 4
Completed	`NCT04884100` - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening	N/A
Completed	`NCT05468281` - RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
Completed	`NCT03627143` - Decreasing Hospital Admissions From the ED for AAFF	N/A
Completed	`NCT02917538` - A Randomized Trial of Contact Force in Atrial Flutter Ablation	N/A
Enrolling by invitation	`NCT05903313` - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Recruiting	`NCT05755074` - Ablation of Typical Right Atrial Flutter	N/A
Recruiting	`NCT05883631` - RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.	N/A
Recruiting	`NCT03272620` - Atrial Fibrillation at the Viennese University Emergency Department	N/A
Completed	`NCT02810938` - MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
Completed	`NCT01914497` - Dipole Density Mapping of Typical Atrial Flutter	N/A
Completed	`NCT02268799` - High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter	N/A
Active, not recruiting	`NCT01976507` - Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism	Phase 4
Completed	`NCT00232310` - Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr	Phase 2