Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 75 years old; 2. Symptomatic, recurrent paroxysmal AF lasting > 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter, 12-lead ECG, event monitor or rhythm strip; 3. The will to accept radiofrequency ablation as a treatment.
Exclusion criteria
Exclusion criteria: 1. Documented LVEF 5.5 cm or moderate to severe LVH (LV wall thickness >1.5cm); 2. Documented valvular disease, coronary heart disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease; 3. Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable; 4. Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation; 5. Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period; 6. Absolute contra-indication to the use of heparin and or warfarin. Or increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy; 7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 8. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction; 9. Women with a positive pregnancy test; 10. Evidence of active cardiac or systemic infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distence between circumferential pulmonary vein simulate ablation line mapping by Mesh mapper or CAR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perimeter and area between circumferential pulmonary vein simulate ablation line mapping by Mesh map; | — |
Countries
China