RecruitingNot ApplicableNCT04715425

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


Sponsor

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

Enrollment

170 participants

Start Date

Sep 25, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for persistent atrial fibrillation (AFib) — a type of irregular heartbeat. It compares minimally invasive chest surgery (thoracoscopic ablation) to catheter ablation, a procedure done through blood vessels, to see which works better for patients whose AFib has not responded to medication. **You may be eligible if:** - You are between 18 and 80 years old - You have persistent AFib confirmed by an ECG or Holter monitor within the past year - At least one anti-arrhythmic medication has failed or was not tolerated - Your heart's left upper chamber is not severely enlarged - You are willing and able to attend follow-up visits **You may NOT be eligible if:** - You have had a prior ablation procedure for AFib - Your AFib is caused by thyroid disease, electrolyte problems, or another reversible cause - You have valvular AFib or paroxysmal (short-burst) AFib - Your AFib has been continuous for more than 1 year - Your BMI is over 35 - You have severe heart failure, a recent heart attack, or active infection - You are pregnant - You have had prior chest surgery or radiation to the chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Bilateral pulmonary vein isolation using radiofrequency energy

PROCEDURECatheter pulmonary vein isolation without additional lesions

Bilateral pulmonary vein isolation using radiofrequency energy


Locations(3)

Amsterdam University Medical Center location AMC

Amsterdam, Netherlands

Maastricht UMC+

Maastricht, Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

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NCT04715425


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