Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture

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.

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.