Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulmonary Vein Isolation: Catheter ablation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standard

Sham-Pulmonary Vein Isolation: Sham-Pulmonary Vein Isolation in deep sedation for at least one hour including femoral vein/artery puncture with introduction of sheaths and electrical cardioversion in presence of current atrial fibrillation

Study summary

Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.

Eligibility

Primary outcome measure(s)

• difference of AFEQT sum scores evaluated at 6 months — 6 months after randomisation compared to baseline
  The primary objective is to show a significant improvement of AF symptoms (measured by AFEQT sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline. Primary endpoint is the difference of AFEQT sum scores between the PVI and the sham-PVI arm, evaluated at 6 months after randomisation.

Trial sites (9)

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