The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated. Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
pulsed field ablation with a large-area focal catheter
KBC Split
Split, Croatia
RECRUITINGSt. Anne's University Hospital
Brno, Czechia
NOT_YET_RECRUITINGHomolka
Prague, Czechia
NOT_YET_RECRUITINGPrimary Safety Endpoint - Rate of Primary Serious Adverse Events
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * Atrio-esophageal fistula (assessed at ≥60 days) * Cardiac perforation, tamponade, or pericardial effusion * Cerebrovascular accident (CVA)/stroke * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in persistent diaphragmatic paralysis (assessed at ≥60 days) * Pulmonary vein stenosis (assessed at ≥60 days) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury/gastroparesis
Time frame: 7 days (unless otherwise specified)
Primary Effectiveness Endpoint - Acute Procedure Success
Percentage of treated pulmonary veins with documented PVI at the end of the index procedure using the study device only. Acute PVI will be assessed by the confirmation of entrance and/or exit block. • Inability to isolate a targeted pulmonary vein with the study device and requiring use of a non-study ablation device to complete PVI will count as an acute procedure failure.
Time frame: During procedure
Chronic PVI Durability
Percentage of treated pulmonary veins with documented PVI at the remapping procedure. Chronic PVI will be assessed by the confirmation of entrance and/or exit block for all pulmonary veins treated at the index procedure.
Time frame: 60 days post-procedure
Acute Success of Additional Atrial Lesion Sets
Percentage of additional atrial lesion sets (PWI, CTI, mitral isthmus) with documented acute procedural success using the study device only.
Time frame: During procedure
12-Month Freedom from Atrial Arrhythmia
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Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes ≥30 seconds duration, after the 60-day Blanking Period following the index ablation procedure, documented by trans-telephonic monitoring (TTM) or Holter monitor through 12 months follow-up.
Time frame: 12 months post-procedure