An interventional study of Three-Dimensional Navigation Atrial Septal Puncture and Conventional Atrial Septal Puncture in Atrial Fibrillation, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Other
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 136 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Device: Three-Dimensional Navigation Atrial Septal Puncture
Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.
Device: Conventional Atrial Septal Puncture
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.
Success 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.
Time frame: one day
（Incidence (%) and frequency (number of events) of (serious) adverse events
（Incidence (%) and frequency (number of events) of (serious) adverse events.
Time frame: one day
Incidence (%) and frequency (number of events) of device-related (serious) adverse events
Incidence (%) and frequency (number of events) of device-related (serious) adverse events.
Time frame: one day
Incidence of device defects and number of events that occurred
Incidence of device defects and number of events that occurred.
Time frame: one day
Plan to share: No
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Tongji Hospital