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Search / Trial NCT04715425

Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jan 18, 2021

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Catheter Ablation Thoracoscopic Ablation

ClinConnect Summary

This clinical trial is comparing two different treatment methods for patients with persistent atrial fibrillation (AF), a common heart rhythm problem. The study aims to find out whether a less invasive catheter ablation or a more invasive thoracoscopic surgical approach is more effective for treating this condition. Participants will be randomly assigned to one of the two methods, and they will be monitored for up to five years to see how well each treatment works in controlling their heart rhythm.

To be eligible for this trial, participants need to be between 18 and 80 years old and have been diagnosed with persistent AF that hasn’t improved with at least one medication. They should also be generally healthy enough to undergo the procedures and committed to attending follow-up visits. Throughout the trial, participants can expect regular heart rhythm checks and, if their AF comes back in the first year, they may receive the other treatment option. This study is important because it aims to provide clearer answers about the best approaches to help patients with persistent AF.

Gender

ALL

Eligibility criteria

  • 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.

About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)

The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.

Locations

Nieuwegein, , Netherlands

Maastricht, , Netherlands

Amsterdam, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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