Atrial Fibrillation
Conditions
Keywords
Atrial septal puncture, Three dimensional, fluroscopy, Catheter Ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEThree-Dimensional Navigation Atrial Septal Puncture
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
DEVICEConventional Atrial Septal Puncture
Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.
Sponsors
Wuhan Greenrhythm Medical Technology Co., LTD
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with atrial fibrillation. 2. Requiring catheter ablation therapy. 3. Voluntarily sign the informed consent.
Exclusion criteria
1. Previous atrial septal puncture. 2. Blood clots in the left atrium or left atrial appendage 3. Left atrial mucinous tumor. 4. Atrial septal defect, including previous surgical correction or interventional occlusion. 5. Acute or severe systemic infection. 6. Cardiac function (NYHA classification) Ⅲ-Ⅳ. 7. Contraindications to anticoagulation. 8. Left ventricular ejection fraction \<35%. 9. Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism. 10. Patients with malignancy with expected survival of less than 1 year. 11. Myocardial infarction or any cardiac intervention or open procedure within the last 3 months 12. Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months. 13. Participated in clinical trials of other drugs or devices in the past 3 months. 14. Any other condition that the investigator deems inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of atrial septal puncture | one day | 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. |
| X-Ray exposure time | one day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial septal puncture duration | one day | 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. |
| First puncture success rate of atrial septum | one day | When the first septal puncture is performed, the puncture sheath is passed through the septal puncture from the right atrium into the left atrium. |
| Total operation time | one day | 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). |
| Performance evaluation of a three-dimensional positioning intracardiac guidance kit | one day | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence (%) and frequency (number of events) of device-related (serious) adverse events | one day | Incidence (%) and frequency (number of events) of device-related (serious) adverse events. |
| （Incidence (%) and frequency (number of events) of (serious) adverse events | one day | （Incidence (%) and frequency (number of events) of (serious) adverse events. |
| Incidence of device defects and number of events that occurred | one day | Incidence of device defects and number of events that occurred. |
Countries
China
Contacts
Primary ContactYan Wang, PhD
Outcome results
None listed