Comparing two methods for treating persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of thoracoscopic surgical ablation versus catheter ablation as primary treatments for patients with persistent atrial fibrillation who have not responded to anti-arrhythmic medications. The research aims to determine which approach provides better outcomes for symptom relief and arrhythmia management. Participants will be monitored for their response to these interventions, focusing on the efficacy and safety of each method. The study is significant as it addresses a gap in existing research regarding these two treatment options.

Why it matters

Who can join: the full rules

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.

Where it's running

• Amsterdam University Medical Center location AMC
  Amsterdam, Netherlands Recruiting
• St. Antonius Ziekenhuis Nieuwegein
  Nieuwegein, Netherlands Recruiting
• Maastricht UMC+
  Maastricht, Netherlands Not yet recruiting

Study contacts

• Study coordinator: J.R. de Groot, MD PhD
• Email: EP-research@amsterdamumc.nl
• Phone: 0205699111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atrioventricular node ablation with conduction system pacing versus drug rate control for HFpEF patients with permanent atrial fibrillation

  This will test whether regularizing heart rate by combining atrioventricular node ablation with physiological (conduction system) pacing lowers deaths or heart-failure hospital stays compared with medication in people with well-controlled permanent atrial fibrillation and HFpEF.

  Recruiting at 7 sites French Cardiology Society · Besançon and 16 other locations · NCT06833138

• Using electrical cardioversion to improve heart rhythm after surgery

  This study tests if using electrical shocks to reset the heart rhythm can help patients with persistent atrial fibrillation feel better after heart surgery.

  Recruiting Saint Petersburg State University, Russia · Saint Petersburg, Sankt-Peterburg · NCT06654401

• Ablation of focal activation in atrial fibrillation

  This study is testing a new method to find specific electrical signals that may be causing ongoing atrial fibrillation in patients, to see if targeting these signals can improve their treatment.

  Recruiting Imperial College London · London · NCT06402617

• New ablation technique for persistent atrial fibrillation

  This study is testing a new treatment for people with persistent atrial fibrillation to see if a combination of techniques can help them feel better and have fewer heart problems compared to standard care.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT06249347

• Comparing two treatments for heart failure patients with atrial fibrillation

  This study is testing two different treatments for heart failure patients with atrial fibrillation to see which one helps them live longer and stay out of the hospital.

  Recruiting at 5 sites University Hospital, Geneva · Graz and 17 other locations · NCT06207383

• Ablation and Isolation for Persistent Atrial Fibrillation Treatment

  This study is testing a new two-step treatment for long-lasting atrial fibrillation to see if it works better than the standard method and helps patients need fewer medications.

  Recruiting Barts & The London NHS Trust · London · NCT06165510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.