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Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation (APPROACH AF)

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ClinicalTrials.gov Identifier: NCT04715425
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation, Persistent Procedure: Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation Procedure: Catheter pulmonary vein isolation without additional lesions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thoracoscopic ablation
Thoracoscopic ablation
Procedure: Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation
Bilateral pulmonary vein isolation using radiofrequency energy

Active Comparator: Catheter ablation
Catheter ablation
Procedure: Catheter pulmonary vein isolation without additional lesions
Bilateral pulmonary vein isolation using radiofrequency energy




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    - Cost-effectiveness of both procedures in isolation, and the combination of both procedures

  5. Quality of life [ Time Frame: 5 years of follow-up ]
    Quality of life as determineed by AFEQT questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715425


Contacts
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Contact: J.R. de Groot, MD PhD 0205699111 EP-research@amsterdamumc.nl

Locations
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Netherlands
Amsterdam University Medical Center location AMC Recruiting
Amsterdam, Netherlands
Maastricht UMC+ Not yet recruiting
Maastricht, Netherlands
St. Antonius Ziekenhuis Nieuwegein Recruiting
Nieuwegein, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Responsible Party: J.R. de Groot, prof. dr. J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04715425    
Other Study ID Numbers: NL63978.018.18
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Catheter ablation
Thoracoscopic ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes