Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Three-Dimensional Navigation Atrial Septal Puncture; Device: Conventional Atrial Septal Puncture

• Registration Number: NCT06188351
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study Start: 2023-04-24
• Study First Submitted: 2023-11-19
• Status Verified: 2023-12
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-Dimensional Navigation Atrial Septal Puncture	Three-Dimensional Navigation Atrial Septal Puncture	Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Conventional Atrial Septal Puncture	Conventional Atrial Septal Puncture	Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China