Persistent Atrial Fibrillation
Conditions
Brief summary
The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.
Interventions
PROCEDUREAtrial Fibrillation Termination
Pursuing Atrial Fibrillation Termination as a Procedural Endpoint
PROCEDUREPrespecified Ablation
Prespecified Ablation Strategy Followed by Cardioversion
Sponsors
The Shanghai Yangpu Central Hospital
Jinshan Hospital Affiliated to Fudan University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged between 18 and 80 years old; 2. Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure; 3. Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month; 4. Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 5. Patients must be able and willing to provide written informed consent to participate in this study; 6. Patients must be willing and able to comply with all study follow- up requirements.
Exclusion criteria
1. .Uncontrolled congestive heart failure, EF \<35%; 2. . History of severe valve disease and/or prosthetic valve replacement; 3. . Myocardial infarction or stroke within 6 months; 4. . Severe congenital heart disease; 5. . Left atrial diameter ≥60mm; 6. . Contrast agent allergy; 7. . The use of anticoagulant drugs is contraindicated; 8. . Severe lung disease; 9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound; 10. .Contraindications for cardiac catheterization; 11. .Prior left atrial ablation (surgical or catheter); 12. .Have performed any cardiac surgery within 2 months; 13. .Poor general health; 14. .Life expectancy \< 12 months, including factors such as physical inability to tolerate ablation or unstable disease conditions.-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months； | 12 months |
| Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months | 12 months |
| Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months | 12 months |
| Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure | 12 months |
| Incidence of periprocedural adverse events. | 12 months |
Countries
China
Outcome results
None listed