Using a 3D navigation kit for atrial septal puncture in heart procedures
A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture
NA · Tongji Hospital · NCT06188351
This study tests if a new 3D navigation kit can make heart procedures safer and more accurate for patients with atrial fibrillation who need catheter ablation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06188351 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with atrial fibrillation who require catheter ablation therapy.
Not a fit: Patients with previous atrial septal puncture or significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the precision of atrial septal punctures, leading to better outcomes for patients undergoing catheter ablation.
How similar studies have performed: While traditional methods have been widely used, the three-dimensional navigation approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan, Hubei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Atrial septal puncture, Three dimensional, fluroscopy, Catheter Ablation