Clinical trial NCT03946280: Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
Official title: Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auricular Flutter
Radiation Exposure
Keywords: ALARA
radiation exposure
Flutter ablation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study, patients are allocated to 1 of the 2 groups
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants
timeFrame: through study completion, an average of 2 year
measure: age
timeFrame: at the moment the patient was recruited for the study
measure: Electrophysiology procedure time (EP time)
timeFrame: at the moment of the intervention
measure: Radiofrecuency ablation time
timeFrame: at the moment of the intervention
measure: Total Fluoroscopy time
timeFrame: at the moment of the intervention
measure: Time without fluoroscopy
timeFrame: at the moment of the intervention
measure: Dose area product
timeFrame: at the moment of the intervention
measure: Radiation dose TLD in patient (5 TLD)
timeFrame: at the moment of the intervention
measure: Radiation dose TLD in operator (3 TLD)
timeFrame: at the moment of the intervention
measure: readmission
timeFrame: within 12 months following the EP
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: Cliniques Universitaires St Luc
name: Christophe Scavée, PhD
role: PRINCIPAL_INVESTIGATOR
References: