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Compares treatment options for Atrial Fibrillation, Persistent
Official title Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT04715425
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Maastricht, Netherlands
- Nieuwegein, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Maastricht, Netherlands; Nieuwegein, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.