Atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients age is * 18 years - Patients with persistent or longstanding persistent atrial fibrillation. - Patients undergoing a first time invasive treatment procedure for persistent atrial fibrillation - AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device. - Patients must give informed consent to participate
Exclusion criteria
Exclusion criteria: - Patients suffering from paroxysmal atrial fibrillation - Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the left atrium, such as pregnancy or presence of a left atrial thrombus - Patients with any contra-indications for VATS such as pleural adhesions, elevated hemidiaphragm or prior lung/cardiac surgery - Active infection or sepsis - Body mass index> 40 - mitral or aortic valve regurgitation above grade 2 - moderate to severe mitral or aortic stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Success after 1 procedure with a follow-up duration of 12 months. Success is defined as: freedom of atrial fibrillation/atrial flutter/atrial tachycardia >30 seconds following the 3 months blanking period in the absence of Class I and III AAD therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -The incidence of periprocedural complications. -Clinical success (75% or greater reduction in the number of AF episodes, the duration of AF episodes, or the % time a patient is in AF in the presence or absence of previously ineffective AAD therapy) after the first procedure. -Procedural duration. -Success and clinical success after 2 procedures with a follow-up duration of 12 months. A second procedure will be performed through catheter ablation in both groups. -Quality of life measurements before and 6 months after the first procedure. | — |
Countries
The Netherlands