This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.
Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes. This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
136
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGSuccess rate of atrial septal puncture
Successful atrial septal puncture is defined as the right and left interatrial pathways are established and the ablation catheter can enter the left atrium smoothly for subsequent ablation operations.
Time frame: one day
X-Ray exposure time
X-ray exposure time from the successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
Time frame: one day
First puncture success rate of atrial septum
When the first septal puncture is performed, the puncture sheath is passed through the septal puncture from the right atrium into the left atrium.
Time frame: one day
Atrial septal puncture duration
Time taken from the time the puncture needle enters the dilator to the time when heparin saline is applied to flush the sheath after the external sheath enters the left atrium.
Time frame: one day
Total operation time
Time taken from the start of successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
Time frame: one day
Performance evaluation of a three-dimensional positioning intracardiac guidance kit
The investigators evaluated the products in terms of pushing performance, retraction performance, torsional control performance, bending resistance/kinking resistance in dilator, catheter sheath, and blood; and tracking performance of the guidewire, catheter sheath, and puncture needle in the 3D calibration system, respectively.
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Time frame: one day