minimaal invasieve interventie atrial fibrillation
Conditions
Interventions
Percutaneous catheter ablation (n=104) versus video-assisted epicardial
ablation and left atrial appendage exclusion (n=52). 2:1 randomization
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients > 18 years of age * Documented, symptomatic, episodes of paroxysmal or persistent AF * During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug. * Able of providing informed consent
Exclusion criteria
Exclusion criteria: * Pregnancy * Unwillingness to use or contra-indications for vitamin K antagonists * Severely enlarged left atrium (>50 mm) on echocardiography * Prior AF ablation or AF surgery * Intracardiac thrombus * Prior heart surgery or pulmonary disease hampering thoracoscopic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include the duration and cost of hospitalization, discomfort during admission, assessment and experienced AF burden during follow-up of procedural impact on the patient and time to recurrence after intervention. A complication register will also be kept. | — |
Countries
Netherlands
Outcome results
None listed