Status:
UNKNOWN
Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Wuhan Greenrhythm Medical Technology Co., LTD
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 ac...
Eligibility Criteria
Inclusion
- Diagnosed with atrial fibrillation.
- Requiring catheter ablation therapy.
- Voluntarily sign the informed consent.
Exclusion
- Previous atrial septal puncture.
- Blood clots in the left atrium or left atrial appendage
- Left atrial mucinous tumor.
- Atrial septal defect, including previous surgical correction or interventional occlusion.
- Acute or severe systemic infection.
- Cardiac function (NYHA classification) Ⅲ-Ⅳ.
- Contraindications to anticoagulation.
- Left ventricular ejection fraction \<35%.
- Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Patients with malignancy with expected survival of less than 1 year.
- Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
- Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
- Participated in clinical trials of other drugs or devices in the past 3 months.
- Any other condition that the investigator deems inappropriate for participation in this trial.
Key Trial Info
Start Date :
April 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06188351
Start Date
April 24 2023
End Date
September 1 2024
Last Update
January 3 2024
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030