Comparing two methods for treating persistent atrial fibrillation
Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
This study is testing whether a surgical procedure or a catheter procedure works better for helping people with persistent atrial fibrillation who haven't found relief from medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Amsterdam and 2 other locations) |
| Trial ID | NCT04715425 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with persistent atrial fibrillation who have failed at least one anti-arrhythmic drug.
Not a fit: Patients with prior interventions for atrial fibrillation or those with conditions causing secondary atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from persistent atrial fibrillation.
How similar studies have performed: While catheter ablation is a common treatment, this study is novel as it directly compares it with thoracoscopic ablation in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam and 2 other locations
- Amsterdam University Medical Center location AMC — Amsterdam, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Netherlands (Not_yet_recruiting)
- St. Antonius Ziekenhuis Nieuwegein — Nieuwegein, Netherlands (Recruiting)
Study contacts
- Study coordinator: J.R. de Groot, MD PhD
- Email: EP-research@amsterdamumc.nl
- Phone: 0205699111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.