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

Not Applicable

• Conditions: Radiation Exposure; Auricular Flutter
• Interventions: Procedure: conventional X-ray based Fluoroscopy; Procedure: low X-ray 3D navigation technique

• Registration Number: NCT03946280
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy Group	conventional X-ray based Fluoroscopy	Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking
3D Group	low X-ray 3D navigation technique	Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques Universitaires St Luc; 🇧🇪 Bruxelles, Belgium