Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry

Study Overview
=================
Brief Summary
-----------------
Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Compared with fluoroscopy, the gold standard X-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. Besides Practical Guidelines as low as reasonably achievable (ALARA) to minimize and normalize radiation exposure had been published so far. The risk of developing acute radiation associated injuries still remains high. In the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (CTI) ablation using either the 3D navigation (Ensite NavX system) (n = 25) or conventional fluoroscopy (n = 25). Further developing the 3D navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (EP) interventional procedures.

Official Title
-----------------
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry

Conditions
-----------------
Auricular Flutter, Radiation Exposure

Intervention / Treatment
-----------------
* Procedure: conventional X-ray based Fluoroscopy
* Procedure: low X-ray 3D navigation technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sick adult patients with Atrial Flutter arrythmia patients able to consent. patients scheduled to receive cavotricuspid isthmus ablation treatment Exclusion Criteria: patients who do not meet inclusion criteria

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized study, patients are allocated to 1 of the 2 groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fluoroscopy Group<br>Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking | Procedure: conventional X-ray based Fluoroscopy<br>* catheter tracking via conventional X-ray based Fluoroscopy<br>|
| Experimental: 3D Group<br>Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking | Procedure: low X-ray 3D navigation technique<br>* catheter tracking via low X-ray 3D navigation technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants | two groups and 25 patiens within each group | through study completion, an average of 2 year | 
| age | age in years of every patient in the study | at the moment the patient was recruited for the study | 
| Electrophysiology procedure time (EP time) | time the intervention last in minutes | at the moment of the intervention | 
| Radiofrecuency ablation time | time radiofrecuency are applied within the EP time in minutes/ seconds | at the moment of the intervention | 
| Total Fluoroscopy time | time the patiens receive x ray radiation along the intervention in minutes/ seconds | at the moment of the intervention | 
| Time without fluoroscopy | time the patiens do not receive any x ray radiation along the intervention in minutes/ seconds | at the moment of the intervention | 
| Dose area product | Global Radiation dose emited by the x-ray tube in mgcm2 | at the moment of the intervention | 
| Radiation dose TLD in patient (5 TLD) | five thermoluminescent dosimeters are placed on the body of the patient in mgcm2 | at the moment of the intervention | 
| Radiation dose TLD in operator (3 TLD) | three thermoluminescent dosimeters are placed on the body of the patient in mgcm2 | at the moment of the intervention | 
| readmission | times the patient is readmitted in the hospital | within 12 months following the EP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALARA, radiation exposure, Flutter ablation