None listed
Conditions
Interventions
None listed
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age =20 years, <80 years (2) Drug refractory symptomatic persistent AF diagnosed within 3 years (3) Either two conditions 1) AF episode lasting longer than 7 days, but less than 3 years documented by consecutive ECG recordings of 100% AF greater than 7 days apart or 2) AF episode requiring electrical or pharmacological cardioversion after 24 hours of AF documented by continuous recording
Exclusion criteria
Exclusion criteria: (1) Long-standing persistent AF more than 3 years (2) Previous ablation procedure or surgery for AF (3) Contraindication to chronic anticoagulation therapy or heparin (4) Documented left atrial diameter >50 mm from parasternal long-axis view (5) A percutaneous coronary intervention or myocardial infarction =3 months (6) A stroke or transient ischemic attack =6 months (7) Planned cardiovascular intervention (8) Mental or physical inability to participate in the study (9) Participation in another randomized clinical trial (10) Uncontrolled hypertension, untreated hypothyroidism or hyperthyroidism (11) Requirement for dialysis due to terminal renal failure (12) Recurrent sinus rhythm after electrical cardioversion (13) Sinus rhythm at enrollment (14) Severe left ventricular dysfuncion (LV ejection fraction < 30%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of ILR-detected AF/AT burden during the first year after PVI compared to pre-ablation AF/AT burden | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first recurrence of AF/AT, lasting for 30 seconds or more;Recurrence nature of AF (paroxysmal or persistent);Symptoms of AF assessed with the use of the modified European Heart Rhythm Association symptom classification; range, 1 to 4;Quality of life assessed with the use of the Medical Outcomes Study 36-Item Short-From Health Survey [SF-36] | — |
Countries
Korea, Republic of
Contacts
Public ContactJihee Min
Seoul National University Hospital
Outcome results
None listed