Auricular Flutter, Radiation Exposure
Conditions
Keywords
ALARA, radiation exposure, Flutter ablation
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.
Interventions
PROCEDUREconventional X-ray based Fluoroscopy
catheter tracking via conventional X-ray based Fluoroscopy
PROCEDURElow X-ray 3D navigation technique
catheter tracking via low X-ray 3D navigation technique
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized study, patients are allocated to 1 of the 2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Electrophysiology procedure time (EP time) | at the moment of the intervention | time the intervention last in minutes |
| 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 |
| 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 |
Countries
Belgium
Contacts
Primary ContactChristophe Scavée, PhD, MD
Backup ContactYovan Sanchez Ruiz, PhD
Outcome results
None listed