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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Auricular Flutter Radiation Exposure

conventional X-ray based FluoroscopyPROCEDURE

catheter tracking via conventional X-ray based Fluoroscopy

low X-ray 3D navigation techniquePROCEDURE

catheter tracking via low X-ray 3D navigation technique

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cliniques Universitaires St Luc

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

Number of Participants

two groups and 25 patiens within each group

Time frame: through study completion, an average of 2 year

age

age in years of every patient in the study

Time frame: at the moment the patient was recruited for the study

Electrophysiology procedure time (EP time)

time the intervention last in minutes