Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) 18 =age = 75 years old, regardless of gender; (2) Subjects confirmed to have paroxysmal atrial fibrillation by surface electrocardiogram [considering the characteristics of paroxysmal atrial fibrillation, previous atrial fibrillation electrocardiograms were accepted, with no restrictions on the examination time and examination institution, and the researchers judged whether the previous electrocardiograms met the requirements.], and subjects who had participated in the "Clinical Trial of the Short-term Effectiveness and Safety of Cardiac Electrophysiological Interventional Device Control System Combined with Disposable Electrophysiological Interventional Device Support for Assisted Atrial Fibrillation Catheter Ablation (Protocol Number: MAXC-CTO-HN-2021-0047)" and completed 3-month follow-up after surgery; (3) Subjects or their guardians were able to understand the purpose of the study, showed sufficient compliance with the study protocol, and signed the informed consent.
Exclusion criteria
Exclusion criteria: (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 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 |
|---|---|
| Postoperative recurrence rate;Atrial fibrillation quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical complication rate;Adverse event rate;Incidence of serious adverse events; | — |
Countries
China
Contacts
The First Affiliated Hospital of Wenzhou Medical University