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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.
ZNA Middelheim
Antwerp, Belgium
Na Homolce Hospital
Prague, Czechia
"Herz- und Diabeteszentrum NRW Klinik für Kardiologie"
Bad Oeynhausen, Germany
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
Safety: • Evaluating the proportion of subjects free from experiencing Serious Adverse Events related to the catheter ablation procedure (Major Adverse Events's or safety events) within the first three (3) months after the treatment. Major adverse events (MAE, Safety events) associated with the catheter ablation procedure include: * Cardiac tamponade * Thromboembolic events including pulmonary embolism and stroke * Complete heart block * Acute myocardial infarction * Phrenic nerve palsy * Atrio-esophageal fistula * Vascular complications * Death
Time frame: < month-3
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