Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry (DOSIMETRY-AFL)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Auricular Flutter; Radiation Exposure

Treatments: Procedure: low X-ray 3D navigation technique; Procedure: conventional X-ray based Fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03946280

DOSIMETRY - FLUTTER

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Fluoroscopy Group

Other group

Description:

Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking

Treatment:

Procedure: conventional X-ray based Fluoroscopy

3D Group

Experimental group

Description:

Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking

Treatment:

Procedure: low X-ray 3D navigation technique