Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)

Technische Universität Dresden

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Radio-frequency catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02137798

EK474122013

CARTOUNIVU (Other Grant/Funding Number)

Details and patient eligibility

About

To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

Full description

The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.

The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.

The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• documented atrial fibrillation in the 12-lead ECG or Holter ECG
• Paroxysmal symptomatic atrial fibrillation
• Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
• Age 18-75 years
• left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
• A signed consent form

Exclusion criteria

• Reversible etiology of atrial fibrillation
• Pregnancy
• Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
• Intracardiac thrombus
• Contraindication to anticoagulation
• Thromboembolic event in the last 6 months
• Previous left atrial ablation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CARTOUNIVU

Experimental group

Description:

Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system

Treatment:

Device: Radio-frequency catheter ablation

CARTO3

Active Comparator group

Description:

Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique

Treatment:

Device: Radio-frequency catheter ablation