Atrial Fibrillation Clinical Trial
Official title:
A Clinical Trial for the Assessment of the Safety and Performance of the Vimecon Laser Cardiac Ablation Instrument (CAI) for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
The objective of this clinical investigation is to confirm the safety and performance of the
Vimecon® Laser Cardiac Ablation Instrument when creating scar tissue within the cardiac wall
for the treatment of atrial fibrillation.
Up to 66 patients with paroxysmal atrial fibrillation refractory to at least one
antiarrhythmic medications (Class I or III) are enrolled. with an expected 10% dropout; 59
per protocol patients are required.
The study duration will be 18 month with a 6 month enrollment period and 12 month follow-up.
Interim follow-up visits are at post procedure, 1 Month, 3 Months, 6 Months and 12 Months.
The baseline and follow up tests are standard of care. Additional optional tests are an
esophageal endoscopy for determination of potential fistula formation and a cerebral MRI for
micro embolism post treatment.
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