Atrial fibrillation
Conditions
Interventions
Single-use Magnetic Positioning Microelectrode Radiofrequency Ablation Catheter Study Group:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have the ability to understand and voluntarily sign the informed consent form with the date, promise to comply with the study procedures, and have good clinical compliance to cooperate with the implementation of the whole process of the study; 2. Patients with clinical diagnosis of atrial fibrillation or symptomatic supraventricular tachycardia: (1) For patients with atrial fibrillation, atrial fibrillation or ambulatory ECG recording (including single-lead ECG recorder) recorded by surface ECG within 1 year prior to enrollment; (2) for patients with symptomatic supraventricular tachycardia, PSVT (AVNRT or AVRT) documented by ECG, Holter, or electrophysiological studies; 3. Patients who are ineffective or intolerant after treatment with at least one anti-arrhythmic drug, or who are still willing to undergo ablation surgery without medication; 4. New York Cardiac Function Grading (NYHA) grades I-II; 5. Left ventricular ejection fraction (LVEF) greater than 50%; 6. Antiarrhythmic drugs should be discontinued for 5 half-lives before surgery; 7. 18 years old<=patient's age<=75 years, gender is not limited;
Exclusion criteria
Exclusion criteria: 1.Left atrial thrombus (not assessed in PSVT cases); 2.Left atrial anteroposterior diameter >=50 mm (exclusion not applicable to PSVT); 3.LVEF <=40%; 4.History of atrial septal repair or atrial myxoma (exclusion not applicable to PSVT); 5.Presence of active implantable devices (e.g., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]) or other specific devices that may interfere with the study intervention's efficacy. 6.NYHA III-IV; 7.Patients with a confirmed diagnosis of cerebrovascular disease (including cerebral hemorrhage, stroke, or transient ischemic attack [TIA]) within the preceding 3 months. 8.Patients with cardiovascular events within the past 3 months (including acute myocardial infarction [AMI], percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], prosthetic valve replacement or repair, or surgical procedures such as atriotomy/ventriculotomy). 9.Patients with acute or severe systemic infection within one month prior to screening. 10.Patients with severe hepatic or renal diseases, malignancy, end-stage diseases, or other conditions deemed by the investigator to potentially interfere with the treatment, evaluation, or compliance of the study. 11.Pregnancy or lactation; 12.Patients with significant bleeding tendencies, hypercoagulable states, or severe hematologic disorders; 13.Patients with severe mental health disorders or other physical health conditions that may interfere with the study intervention’s efficacy; 14.Patients with any other conditions deemed by the investigator as unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute procedural success rate following catheter ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surface temperature variation of ablated tissue;Incidence of adverse events related to investigational device during the perioperative period;Changes in impedance at the ablation point;Procedural Evaluation Parameters Evaluation;System Compatibility Evaluation; | — |
Countries
China
Contacts
Public ContactQI Jin
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed