Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry (DOSIMETRY-AFL)

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.

Study Overview

• Status: Unknown
• Conditions: Radiation Exposure; Auricular Flutter
• Intervention / Treatment: Procedure: conventional X-ray based Fluoroscopy; Procedure: low X-ray 3D navigation technique

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Scavée, PhD, MD; Phone Number: +3227642808; Email: christophe.scavee@uclouvain.be
• Study Contact Backup: Name: Yovan Sanchez Ruiz, PhD; Email: Yovan.sanchezruiz@student.uclouvain.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires St Luc
    • Contact: Yovan SANCHEZ RUIZ; Email: ysanchezruiz@student.uclouvain.be
    • Contact: Christophe SCAVEE; Phone Number: 3227642808; Email: christophe.scavee@uclouvain.be
    • Principal Investigator: Christophe Scavee, Phd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Christophe Scavée, PhD, Cliniques Universitaires St Luc

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: radiation exposure; ALARA; Flutter ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: DOSIMETRY - FLUTTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No