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NCT Number: NCT04715425

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

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.

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Key information

Conditions

Atrial Fibrillation, Persistent Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center location AMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation

Procedure

Bilateral pulmonary vein isolation using radiofrequency energy

Catheter pulmonary vein isolation without additional lesions

Procedure

Bilateral pulmonary vein isolation using radiofrequency energy

Primary outcomes

  1. Freedom of AF, defined as absence of any atrial tachyarrhythmia

    Time frame: Up until 72 patients experienced AF recurrence

    The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached. This is an event based endpoint. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study.

Secondary outcomes

  1. One year freedom of AF

    Time frame: 1 year of follow-up

    Freedom of arrhythmia with or without AAD after a single procedure after one year

  2. Freedom of AF after two procedures

    Time frame: 1 year of follow-up after the second procedure

    Freedom of arrhythmia after 12 months with or without AAD after both procedures

  3. Long term freedom of AF

    Time frame: 5 years of follow-up

    Freedom of arrhythmia after 5 years

  4. Cost-effectiveness

    Time frame: 1 year of follow-up

    calculation of cost-effectiveness of both procedures in isolation, and the combination of both procedures.

  5. Quality of life after a thoracoscopic surgical procedure or a catheter ablation procedure.

    Time frame: Yearly until 5 years follow-up

    Quality of life score of all patients, in both groups. We use the general (EQ5D) and AF specific (AFEQT) quality of life outcome questionaires.

Study contacts

Contact information is provided by the study sponsor or research team.

J.R. de Groot, MD PhD

CONTACT

[email protected]

0205699111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: APPROACH AF

Important dates

Study start
2019
Primary completion
2024
Study completion
2028
First posted
Jan 20, 2021
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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