Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillatio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 170

Inclusion Criteria

Age is between 18 and 80 years.
- Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
- AF documented by ECG or Holter < 1 year ago.
- At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
- Left atrial volume index = 45 ml/m2
- Legally competent and willing to sign the informed consent.
- Willing and able to adhere to the follow-up visit protocol.
- Life expectancy of at least 2 years.

Exclusion Criteria

- Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
- AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
- Documentation of CTI dependent atrial flutter
- Valvular AF
- Paroxysmal AF
- Long standing Persistent AF, defined as AF continuously present for longer than 1 year.
- Body mass index >35kg/m2
- NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%.
- NYHA class III heart failure symptoms, unless caused or aggravated by AF.
- Myocardial infarction within the preceding 2 months.
- Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C).
- Known and documented carotid stenosis > 80%
- Planned cardiac surgery for other purposes than AF.
- Pregnancy or child bearing potential without adequate anticonception.
- Requirement of anti-arrhythmic drugs for ventricular arrhythmias.
- Presence of intracardiac mass or thrombus (discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the subject from the study)
- Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator).
- History of previous radiation therapy on the thorax
- Circumstances that prevent follow-up
- No vascular access for catheterization.
- History of previous thoracotomy.
- Factors precluding transseptal puncture for catheterization. Sample size

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
- Freedom of arrhythmia with or without AAD after a single procedure after one year<br>- Freedom of arrhythmia after 12 months with or without AAD after both procedures<br>- Freedom of arrhythmia after 5 years<br>- Cost-effectiveness of both procedures in isolation, and the combination of both procedures<br>- Quality of life

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