Atrial Fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 18-75 years; 2) Symptomatic paroxysmal AF; 3) At least one ECG documented AF within 6 months of the ablation procedure; 4) Patient is able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) >4 cardioversions in prior 12 months; 2) MI, CABG or PCI within preceding 3 months; 3) Left atrial diameter >50mm; 4) Left ventricular ejection fraction by echocardiography <40%; 5) Heart failure with NYHA class III or IV; 6) History of heart surgery or any previous ablation for AF; 7) Intracardiac thrombus; 8) Contradictions to anticoagulation; 9) Females who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from AF/AFL/ATa recurrences at 12 months following ablation, without antiarrhythmic drug (type I/III) therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from AF/AFL/ATa recurrences at 12 months following ablation, with or without antiarrhythmic drug (type I/III) therapy;Proportion of patients with AF/AFL/ATa occurring during the first 90 days post ablation;;Repeat ablation procedure due to recurrence of AF/AFL/ATa;AI-related parameters and the ratio of first-pass isolation;Total procedure duration, X-ray exposure time, PV isolation time;Incidence of peri-procedural complications;Quality of life measurements (SF-36); | — |
Countries
China
Contacts
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University