Using a 3D navigation kit for atrial septal puncture in heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a novel three-dimensional navigation intracardiac guidance kit for performing atrial septal puncture in patients with atrial fibrillation who require catheter ablation. The new kit will be compared to traditional two-dimensional guidance methods, which may lack accuracy. The goal is to determine if the three-dimensional approach can improve procedural outcomes and potentially allow for transseptal puncture without fluoroscopy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Yan Wang, PhD — Tongji Hospital Wuhan, Hubei China
• Study coordinator: Yan Wang, PhD
• Email: newswangyan@tjh.tjmu.edu.cn
• Phone: +86-13697326307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.