NCT04715425Recruiting
Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 25 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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-the-art pharmacological therapies targeting the ventricular rate or aiming to restore sinus rhythm, many patients with persistent AF stay symptomatic. Catheter ablation, endocardial pulmonary vein isolation (PVI) in particular, is the most commonly applied approach to treat drug refractory persistent AF, but particularly in this patient group results are modest. Alternatively, the PVs can be approached epicardially by thoracoscopic surgery to isolate the PVs. This approach is more efficacious, at the cost of a more invasive procedure and longer hospital stay. However, no studies have been conducted comparing catheter with thoracoscopic ablation in patients with persistent AF as a primary invasive procedure after failing treatment with anti-arrhythmic medication. Objective: This current study aims to assess a patient specific therapy plan for patients with persistent AF by randomizing thoracoscopic versus catheter ablation for PVI without adjuvant substrate ablation in those patients. Study design: This is a prospective, non-blinded randomized multicenter study. Subjects will be randomized (1:1) to one of the two study-arms (thoracoscopic surgical or catheter PVI). The follow-up will last 5 years, with heart rhythm monitoring at three and six months, one year and yearly in the following years. In case AF recurs during the first year, the subject will receive the treatment of the otherother arm, or according to patient choice or clinical routine. Study population: Patients with an indication for invasive treatment of persistent AF. Intervention: Thoracoscopic surgical or catheter PVI without additional lesions.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 13 Jan 2021
- Start date
- 25 Sept 2019
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Atrial fibrillation
- NCT number
- NCT04715425
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 25 Sept 2019 to the primary completion date, 30 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
- History of previous radiation therapy on the thorax
- History of previous thoracotomy.
Other illness
- AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
- NYHA class III heart failure symptoms, unless caused or aggravated by AF.
- Myocardial infarction within the preceding 2 months.
- Planned cardiac surgery for other purposes than AF.
- Requirement of anti-arrhythmic drugs for ventricular arrhythmias.
- Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator).
Lab values
- NYHA class IV heart failure symptoms or left ventricular ejection fraction \<35%.
- Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever \>38,5 °C).
Other
- 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
- Known and documented carotid stenosis \> 80%
- Pregnancy or child bearing potential without adequate anticonception.
- 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)
- Circumstances that prevent follow-up
- No vascular access for catheterization.
- Factors precluding transseptal puncture for catheterization.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| St. Antonius Ziekenhuis Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.