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

NCT04715425 | Recruiting DMC

• 1 other identifier: NL63978.018.18
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation, Persistent

Keywords

Catheter ablation; Thoracoscopic ablation

Outcome Measures

Primary Outcomes (1)

• Freedom of AF, defined as absence of any atrial tachyarrhythmia

  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.

  Up until 72 patients experienced AF recurrence

Secondary Outcomes (5)

• One year freedom of AF

  1 year of follow-up

• Freedom of AF after two procedures

  1 year of follow-up after the second procedure

• Long term freedom of AF

  5 years of follow-up

• Cost-effectiveness

  1 year of follow-up

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

  Yearly until 5 years follow-up

Study Arms (2)

Thoracoscopic ablation

ACTIVE COMPARATOR

Thoracoscopic ablation

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

Catheter ablation

ACTIVE COMPARATOR

Catheter ablation

Procedure: Catheter pulmonary vein isolation without additional lesions

Interventions

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

Bilateral pulmonary vein isolation using radiofrequency energy

Thoracoscopic ablation

Catheter pulmonary vein isolation without additional lesions PROCEDURE

Bilateral pulmonary vein isolation using radiofrequency energy

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (3)

Amsterdam University Medical Center location AMC

Amsterdam, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Netherlands

NOT YET RECRUITING

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amputation, Surgical

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Central Study Contacts

J.R. de Groot, MD PhD

CONTACT

0205699111; EP-research@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. J.R. de Groot

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: September 25, 2019
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)