Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

Tongji Hospital

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Conventional Atrial Septal Puncture; Device: Three-Dimensional Navigation Atrial Septal Puncture

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06188351

3DASP study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Three-Dimensional Navigation Atrial Septal Puncture

Experimental group

Description:

Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit

Treatment:

Device: Three-Dimensional Navigation Atrial Septal Puncture

Conventional Atrial Septal Puncture

Active Comparator group

Description:

Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method.

Treatment:

Device: Conventional Atrial Septal Puncture