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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03946280
Other study ID # DOSIMETRY - FLUTTER
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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