atrial fibrillation? paroxysmal supraventricular tachycardia
Conditions
Interventions
Control group:Transseptal Puncture Needle and Intracardiac Guiding Sheath Set
Test group:AccuSafe Transseptal Puncture Guidewire and Matching Controllable Curved Sheath Set
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient age >= 18 years old and <= 75 years old; 2. Confirmed diagnosis of atrial fibrillation or paroxysmal supraventricular tachycardia requiring catheter ablation surgery; 3. Able to understand the purpose of the trial and willing to undergo the follow-up and evaluation as required by the protocol; 4. Agree to participate in this clinical trial and be able to sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. History of previous atrial septal puncture; 2. Suffered from myocardial infarction and unstable angina pectoris within the past two weeks; 3. Systemic arterial embolism occurred within the past four weeks; 4. Cerebrovascular accident (CVA) occurred within the past four weeks; 5. Has previously undergone surgical repair of atrial septal defect with a polyester patch or suffers from left atrial myxoma; 6. Disconnection of the inferior vena cava or other congenital structural heart diseases; 7. Thrombocytopenia in patients (PLT<80×10?/L), or presence of contraindications to anticoagulation (such as warfarin, heparin, direct factor Xa inhibitors, etc.); 8. Anteroposterior diameter of left atrium = 55mm; 9. Left atrial thrombus; 10. Severe organic heart diseases (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe valvular heart disease); 11. LVEF<30%; 12. Thyroid function indicators exceed the normal range and may affect surgical safety or research results after clinical evaluation; 13. Severe insufficiency of liver and kidney function; 14. History of surgical operations in the past 3 months; 15. Patients with systemic active infection judged by the investigator to be ineligible for interventional therapy; 16. Pregnant or lactating women; 17. Patients participating in other clinical trials of drugs or medical devices; 18. Other patients deemed unsuitable for participation in this trial by the researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint for the efficiency of transseptal puncture procedure, including: 1) Transseptal puncture time; 2) First-pass puncture success rate;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Learning Curve Evaluation;Incidence of Complications (TSP-related Adverse Events);Puncture Point Displacement (Cases with ICE Data);Puncture times;Operator's Operational Satisfaction; | — |
Countries
China
Contacts
Public ContactLi Ning
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed