Atrial Fibrilation disorder of the Atrail Rhythm
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Symptomatic Recurrent Persistent AF or Long Standing Persistent AF, for > 1 year and
Exclusion criteria
Exclusion criteria: Documented left atrial size greater than 55 mm. Documented LVEF of 40% or less. History of cerebrovascular disease, including stroke or TIA within 6 months prior to enrollment Previous heart surgery COPD (70% predictive lung function) Contraindication to anticaogulant therapy, or inability to comply with anticoagulation therapy Pregnancy, planned pregnancy or breastfeeding Concomitant cardiac surgery procedure planned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the rate of therapeutic success of thoracoscopic surgical ablation, with a target rate of > 60%. Surgical ablation success is defined as freedom from AF without the need for EP ablation, during 12 months after surgery, based on 24-hour Holter monitor results, and freedom from AADs beginning at 6 months following surgery. Arrhytmias during the blanking period (first 3 months after ablation) are excluded from evaluation. The primary safety endpoint is a composite safety endpoint consisting of the incidence of the following early onset serious adverse events (SAEs) (i.e., within 30 days of the last RF ablation procedure) including all cause death, stroke and TIA, myocardial infarction, thromboembolic events, bleeding, access site infection, need for permanent pacemaker, pulmonary vein stenosis, esophageal fistula, cardiac tamponade or pericardial effusion requiring intervention. | — |
Countries
Netherlands
Outcome results
None listed