A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Tongji Hospital
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Success rate of atrial septal puncture
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Yan Wang
Professor
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with atrial fibrillation.
- •Requiring catheter ablation therapy.
- •Voluntarily sign the informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Success rate of atrial septal puncture
Time Frame: 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
Time Frame: 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 Outcomes
- First puncture success rate of atrial septum(one day)
- Total operation time(one day)
- Performance evaluation of a three-dimensional positioning intracardiac guidance kit(one day)
- Atrial septal puncture duration(one day)