Paroxysmal atrial fibrillation
Conditions
Interventions
Experimental Group:The cardiac electrophysiology interventional device control system (RIECS-1, Shaoxing Mayo Magnetic Cardiovascular Medical Technology Co., Ltd.) is combined with the disposable elec
Control group:The researchers manually delivered the cardiac electrophysiology catheter and sheath in the desired direction through the peripheral blood vessels to a specific location in the heart cav
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical trial must meet all of the following criteria: (1) 18 =age = 75 years old, regardless of gender; (2) Patients with paroxysmal atrial fibrillation confirmed by surface electrocardiogram [considering the characteristics of paroxysmal atrial fibrillation, previous atrial fibrillation electrocardiograms are accepted, and the examination time and examination institution are not limited. The researcher shall determine whether the previous electrocardiogram meets the requirements.] and intend to undergo catheter ablation surgery; (3) Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: (1) Patients who have undergone atrial and ventricular surgery within 4 weeks before surgery; (2) Patients who have undergone heart valve replacement surgery; (3) Patients who have undergone unsuccessful or recurrent catheter ablation in the past; (4) Patients with systemic infection; (5) Patients with thromboembolic diseases; (6) Patients with intracardiac thrombus or atrial myxoma; (7) Patients with cardiac and great vessel tumors; (8) Left ventricular ejection fraction (LVEF) = 40%; (9) Patients with NYHA heart function class III-IV; (10) Patients with stroke or other cerebrovascular diseases within 3 months before surgery; (11) Patients who cannot tolerate or cooperate with the completion of surgery; (12) Pregnant or lactating women; (13) Participated in other interventional drug, biological agent or device clinical trials within 1 month before screening; (14) Other situations judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate;Operation time;Ablation time;Cumulative perspective time;Average contact pressure at ablation point;Satisfaction evaluation;Arrhythmia incidence; | — |
Countries
CHINA
Contacts
Public ContactCHANGSHENG MA
Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed