Cryoablation in Patients With Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.

Official Title
-----------------
Cryoablation in Patients With Atrial Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Procedure: Cryoballoon ablation
* Procedure: Implantation of loop recorder
* Procedure: Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years ECG documented paroxysmal or persistent AFL No prior documented history of AF Patient undergoing RFA of the CTI for AFL. No indication (other than AFL) for continued anticoagulation with warfarin. No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device) Availability of an analog phone line. Exclusion Criteria: a history of atrial fibrillation Previous AF ablation procedure Congestive heart failure Left Ventricle ejection fraction less than 35% Unwillingness to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (RFA CTI+Reveal)<br>assessing the incidence of atrial fibrillation in patients with atrial flutter | Procedure: Implantation of loop recorder<br>* The RevealXT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. Patients were provided with the Patient Assistant, a toolthat allows each patient to store the ECG through the implanted device during symptoms: datawere collected in order to analyze heart rhythm during symptomatic events<br>Procedure: Radiofrequency ablation<br>* Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a ﬂow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).<br>|
| Active Comparator: Group 2 (RFA CTI+Cryo PVI+Reveal)<br>efficacy of cryoablation in patients with atrial flutter | Procedure: Cryoballoon ablation<br>* After double transseptal puncture, selective PV angiography was performed to identify the PV ostia in 2 projections (right anterior oblique 30º, left anterior oblique 40 º). Baseline potentials of all PVs were recorded with a Lasso catheter (Biosense Webster, Inc., Diamond Bar, California). To assess the exact position of the inflated balloon in relation to the left atrial (LA)-PV junction, contrast medium was injected from the distal lumen of the cryoballon catheter . CBA was performed for a target time of 300 seconds. The right phrenic nerve was constantly paced from the superior caval vein during freezing at the septal PVs. After each freeze, PV conduction was revaluated by the Lasso catheter.<br>Procedure: Implantation of loop recorder<br>* The RevealXT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. Patients were provided with the Patient Assistant, a toolthat allows each patient to store the ECG through the implanted device during symptoms: datawere collected in order to analyze heart rhythm during symptomatic events<br>Procedure: Radiofrequency ablation<br>* Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a ﬂow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of AF burden |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 3 years | 
| thromboembolic events |  | 3 years | 
| hospitalizations |  | 3 years | 
| procedural complications |  | 3 years | 
| drug adverse effects |  | 3 years | 
| number of crossovers |  | 3 years |