Atrial Fibrillation, Persistent Clinical Trial
Official title:
Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
Despite good progress in the management of patients with atrial fibrillation (AF), this
arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and
cardiovascular morbidity in the world. Furthermore, the number of patients with AF is
predicted to rise steply in the coming years.
Even if the amount of antiarrhythmic drugs (AAD) is constantly increasing, there is a group
of patients who has AF, resistant to AAD therapy. In such cases they are being offered
alternative minimally invasive procedures, such as catheter or thoracoscopic ablation. With
the discovery that AF often is initiated and maintained by electrical instability inside and
around the pulmonary veins (PV) catheter and thoracoscopic ablation are now widely accepted
invasive strategies to cure AF.
Even though the results of both of the procedures are very promising in treating patients
with paroxysmal AF, the decision making process, which approach should be used in patients
with persistant or LSPAF, is still very controversial.
According to 2016 ESC Guidelines for the management of atrial fibrillation developed in
collaboration with EACTS, catheter or surgical ablation should be considered in patients with
symptomatic persistent or long-standing persistent (LSP) AF refractory to AAD therapy to
improve symptoms, considering patient choice, benefit and risk, supported by an AF Heart Team
(IIaC).
Since, there is no actual evidence base, which approach is more effective and save in
patients with persistant and LSP AF, the aim of the investigator's study is to evaluate the
results of both of the approaches in such group of patients.
The aim of this study is to compare 2 approaches for AF treatment, endocardial catheter
isolation of the pulmonary veins (PV) versus minimally invasive thoracoscopic surgical
epicardial ablation.
The patients in both groups will be comparable and have persistant or LSP AF only. Patients
with previous catheter ablations or any interventions or open heart procedures in the
anamnesis will be excluded. The catheter ablation will be Ablation Index-guided, which means
that every ablation point will be taken according to ablation quality marker which corporates
power, delivery time, contact force (CF), and catheter stability, called Ablation Index (AI).
Both of the procedures will be performed by a single identical protocol including wide
complete circumferential ablation around the right and left PVs, and additional lines between
the lower and upper PVs. The thoracoscopic procedure will be supplemented with removal of
left atrial appendage (LAA).
In cases of AF or other atrial tachycardia recurrence after both procedures, every patient
will undergo the opposite procedure (for example, if patient after thoracoscopic ablation
will be diagnosed an AF recurrence, he will undergo catheter ablation). That is why there
will be the third group, the so-called Hybrid procedure group of patients.
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