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

NCT04715425 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-01-25

No results posted yet for this study

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

Interventions

PROCEDURE

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

Bilateral pulmonary vein isolation using radiofrequency energy

PROCEDURE

Catheter pulmonary vein isolation without additional lesions

Bilateral pulmonary vein isolation using radiofrequency energy

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2024-09-30
Completion
2028-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715425 on ClinicalTrials.gov