Rationale: Atrial fibrillation (AF) is a highly prevalent cardiac arrhythmia. AF is classified as paroxysmal or persistent AF, based on the duration and persistency of the arrhythmia. Despite state-of-the-art pharmacological therapies targeting the ventricular rate or aiming to restore sinus rhythm, many patients with persistent AF stay symptomatic. Catheter ablation, endocardial pulmonary vein isolation (PVI) in particular, is the most commonly applied approach to treat drug refractory persistent AF, but particularly in this patient group results are modest. Alternatively, the PVs can be approached epicardially by thoracoscopic surgery to isolate the PVs. This approach is more efficacious, at the cost of a more invasive procedure and longer hospital stay. However, no studies have been conducted comparing catheter with thoracoscopic ablation in patients with persistent AF as a primary invasive procedure after failing treatment with anti-arrhythmic medication. Objective: This current study aims to assess a patient specific therapy plan for patients with persistent AF by randomizing thoracoscopic versus catheter ablation for PVI without adjuvant substrate ablation in those patients. Study design: This is a prospective, non-blinded randomized multicenter study. Subjects will be randomized (1:1) to one of the two study-arms (thoracoscopic surgical or catheter PVI). The follow-up will last 5 years, with heart rhythm monitoring at three and six months, one year and yearly in the following years. In case AF recurs during the first year, the subject will receive the treatment of the otherother arm, or according to patient choice or clinical routine. Study population: Patients with an indication for invasive treatment of persistent AF. Intervention: Thoracoscopic surgical or catheter PVI without additional lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Bilateral pulmonary vein isolation using radiofrequency energy
Bilateral pulmonary vein isolation using radiofrequency energy
Amsterdam University Medical Center location AMC
Amsterdam, Netherlands
RECRUITINGMaastricht UMC+
Maastricht, Netherlands
NOT_YET_RECRUITINGSt. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands
RECRUITINGFreedom of AF, defined as absence of any atrial tachyarrhythmia
The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached. This is an event based endpoint. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study.
Time frame: Up until 72 patients experienced AF recurrence
One year freedom of AF
Freedom of arrhythmia with or without AAD after a single procedure after one year
Time frame: 1 year of follow-up
Freedom of AF after two procedures
Freedom of arrhythmia after 12 months with or without AAD after both procedures
Time frame: 1 year of follow-up after the second procedure
Long term freedom of AF
Freedom of arrhythmia after 5 years
Time frame: 5 years of follow-up
Cost-effectiveness
calculation of cost-effectiveness of both procedures in isolation, and the combination of both procedures.
Time frame: 1 year of follow-up
Quality of life after a thoracoscopic surgical procedure or a catheter ablation procedure.
Quality of life score of all patients, in both groups. We use the general (EQ5D) and AF specific (AFEQT) quality of life outcome questionaires.
Time frame: Yearly until 5 years follow-up
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