Exploratory Clinical Investigation to evaluate the feasibility and safety of the AblaView® Unipolar Percutaneous Ablation Irrigated Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation using Polarization Sensitive Optical Coherence Reflectometry (PS-OCR) to guide delivery of Pulsed Field Ablation (PFA) lesions - First in Man
Exploratory Clinical Investigation to evaluate the feasibility and safety of the AblaView® Unipolar Percutaneous Ablation Irrigated Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation using Polarization Sensitive Optical Coherence Reflectometry (PS-OCR) to guide delivery of Pulsed Field Ablation (PFA) lesions - First in Man
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Patients with symptomatic paroxysmal atrial fibrillation will be treated with the AblaView® Unipolar PFA System system to achieve electrical isolation of the pulmonary veins. The AblaView® Unipolar PFA Catheter is a regular PFA irrigated catheter. The tip of the catheter has 7 holes distributed around that deliver at the same time irrigation and near infrared light for the OCR system, which will be processed and interpreted by the Console.
Ezgu Niyat
Tashkent, Uzbekistan
Realtime predictability of PFA ablation lesion chronicity
Feasibility: 3-month Validation: Predictability Assessment by PS-OCR and PFA Lesions continuity and chronicity at 3-month remapping. Evaluation of the predictability of chronicity of ablation lesions in terms of Accuracy, Specificity and Sensitivity
Time frame: Up to 3 months
Safety Acute
Serious procedure- and device-related adverse events. Serious adverse events, and their relatedness to the AblaView Unipolar PFA System or procedure will be adjudicated by the Clinical Events Committee. The sites are required to report all adverse events.
Time frame: Up to 3 months
Procedure Parameters
* Skin-to-skin procedural time, minutes * Device left atrial dwell time, minutes * Time between first and last application, minutes * Fluoroscopy time during procedure, minutes * Total amount of PFA energy delivered in, joules. * Number of applications per targeted vein and/or isolation and for complete procedure, number
Time frame: The day of the procedure
Per procedure (Ablation/remapping) optical parameters
* Detection of optical signals to evaluate contact and birefringence in the left atria, yes or no * Detection and quantification of changes in birefringence during ablation, in % * Detection of gaps in the continuous ablation/isolation lines during ablation procedure, yes or no
Time frame: The day of procedure
Procedure Validation
Acute Validation (20 to 30) min at least after the completion of each line/isolation by Electrical and optical isolation of targeted pulmonary veins (PVs), yes or no
Time frame: The day of the procedure
Recurrence
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Recurrence or new occurrence of arrhythmias controlled by Holter 48-hrs and by TTM weekly and triggered by symptoms.
Time frame: Up to 3 months
Improvement in the Quality of Life
* Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score difference between baseline and at 3 month * European Quality of Life-5 Dimensions (EQ-5D-5L) score difference between baseline and at 3 month in total and for mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time frame: At 3 months
Safety at 1 month
MACE (30d)
Time frame: At 1 month
Safety at 3 months
Occurence of Atrial/Ventricular Arrhythmias, Stroke, HF
Time frame: Between 1 month and 3 months