atrial fibrillation
Conditions
Interventions
Pulmonary Vein Isolation(PVI) group:Pulmonary Vein Isolation
Pulmonary Vein Isolation(PVI)+roof line+ left atrial anterior wall linear group:Pulmonary Vein Isolation with roof line and left atrial anterior wall linear
Sponsors
The Second Affiliated Hospital of the Naval Medical University(Shanghai Changzheng Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years, of either gender; 2) Persistent symptomatic atrial fibrillation, which may include but is not limited to palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or any combination of the above five symptoms; 3) Ineffectiveness or intolerance to at least one antiarrhythmic drug treatment; 4) Expected to undergo catheter ablation therapy; 5) Sufficient understanding of the purpose, nature, methods, and potential adverse reactions of the study, voluntary participation, agreement to the follow-up plan, and signing of an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Diagnosed with paroxysmal atrial fibrillation; 2) Atrial fibrillation secondary to reversible causes such as thyroid disease or severe untreated sleep apnea; 3) Contraindications to anticoagulant therapy; 4) Diagnosed with hypertrophic cardiomyopathy; 5) Uncontrolled congestive heart failure (EF<40%); 6) Severe valvular disease/regurgitation or post-valve replacement surgery; 7) Percutaneous coronary intervention (PCI) within three months; 8) Severe congenital heart disease; 9) Severe pulmonary disease; 10) Left atrial appendage thrombus; 11) Contraindications to contrast media, radiofrequency ablation, etc.; 12) Patients in poor general condition or with a life expectancy of less than one year; 13) Prior surgical treatment for atrial fibrillation (including surgical maze procedure, catheter ablation, left atrial appendage occlusion, etc.); 14) Pregnant women, breastfeeding women, or those of childbearing potential not using contraception; 15) Participation in other medical device or drug clinical studies within the previous three months; 16) Any other conditions deemed unsuitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Following a single ablation procedure, there were no recorded instances of atrial arrhythmias (such as atrial fibrillation, atrial tachycardia, or atrial flutter) or events of less than 30 seconds duration, excluding the initial 3-month blanking period, during the 12-month period following the procedure and without the use of AADs.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Following a single ablation procedure, there were no recorded instances of atrial arrhythmias (such as atrial fibrillation, atrial tachycardia, or atrial flutter) or events of less than 30 seconds duration, during the 3-month period following the procedure and without the use of AADs.;Following a single ablation procedure, there were no recorded instances of atrial arrhythmias (such as atrial fibrillation, atrial tachycardia, or atrial flutter) or events of less than 30 seconds duration, during the 6-month period following the procedure and without the use of AADs.;In the 12 months following a single ablation procedure with AADs outside the blanking period, there were no recorded instances of atrial arrhythmias (atrial fibrillation, atrial tachycardia, or atrial flutter) or the recorded instances of these arrhythmias were less than 30 seconds in duration.;Atrial fibrillation burden monitored by 24-hour electrocardiogram during recurrence within 12 months after a single ablation procedure;;The difference in baseline data between patients experiencing atrial arrhythmias (such as atrial fibrillation, atrial tachycardia, or atrial flutter) exceeding 30 seconds within the blank period and those experiencing such arrhythmias after the blank period.;Long-term outcomes of various cardioversion techniques: procedure, Nifekalant-based medication, and electrical cardioversion.;Comparison of quality of life at the baseline and 12 months post-ablation; | — |
Countries
China
Contacts
Public ContactZhang Jiayou
The Second Affiliated Hospital of the Naval Medical University
Outcome results
None listed