NCT03946280

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Auricular Flutter
• Radiation Exposure

Interventions

Type	Name	Description
PROCEDURE	conventional X-ray based Fluoroscopy	catheter tracking via conventional X-ray based Fluoroscopy
PROCEDURE	low X-ray 3D navigation technique	catheter tracking via low X-ray 3D navigation technique

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2019-05-10
• Last updated: 2019-07-16

Locations

1 site across 1 country: Belgium