Status:
RECRUITING
Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Atrial Fibrillation, Persistent
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04715425
Start Date
September 25 2019
End Date
September 1 2028
Last Update
January 25 2024
Active Locations (3)
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1
Amsterdam University Medical Center location AMC
Amsterdam, Netherlands
2
Maastricht UMC+
Maastricht, Netherlands
3
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands