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

Radiation Exposure Clinical Trial

— DOSIMETRY-AFL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03946280
• Other study ID #: DOSIMETRY - FLUTTER
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Christophe Scavée, PhD, MD
• Phone: +3227642808
• Email: christophe.scavee[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Auricular Flutter
• Radiation Exposure

Intervention

Procedure:
• conventional X-ray based Fluoroscopy
catheter tracking via conventional X-ray based Fluoroscopy
• low X-ray 3D navigation technique
catheter tracking via low X-ray 3D navigation technique

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants	two groups and 25 patiens within each group	through study completion, an average of 2 year
Primary	age	age in years of every patient in the study	at the moment the patient was recruited for the study
Primary	Electrophysiology procedure time (EP time)	time the intervention last in minutes	at the moment of the intervention
Primary	Radiofrecuency ablation time	time radiofrecuency are applied within the EP time in minutes/ seconds	at the moment of the intervention
Primary	Total Fluoroscopy time	time the patiens receive x ray radiation along the intervention in minutes/ seconds	at the moment of the intervention
Primary	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
Primary	Dose area product	Global Radiation dose emited by the x-ray tube in mgcm2	at the moment of the intervention
Primary	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
Primary	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
Primary	readmission	times the patient is readmitted in the hospital	within 12 months following the EP