[미국 FDA의 승인 또는 허가를 받지 않은 기기의 임상시험] (VP-CONFIRM)

Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software.

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.

TPI will be reported.

Acute effectiveness, that is, acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported.

PVI durability is defined as sustained isolation of pulmonary vein (PVs) that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 (+/- 14 days) days post index ablation procedure.

PF application time will be reported.

Number of PF applications by PV will be reported.

A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants.

An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

Occurrence of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.

Anatomical location of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.

Size of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.

Occurrence of new or worsening neurological deficits post-ablation and at follow-up, compared to baseline will be assessed.

The MMSE is a, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.

The NIHSS is a clinician-reported measure of neurological deficit with scores ranging from 0 to 42. No stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42).

The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) :

• mRS 0: No symptoms.
• mRS 1: No significant disability. Able to perform all usual activities, despite some symptoms.
• mRS 2: Slight disability. Independent but unable to perform usual activities (work, sports, leisure).
• mRS 3. Moderate disability. Requires assistance, but able to walk alone.
• mRS 4: Moderately severe disability. Walking assistance and/or daily living activities not possible.
• mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention.
• mRS 6: Death.

Occurrence of severe PV stenosis up to 3 months post-ablation as determined by Computed Tomography (CT)/ Magnetic Resonance Angiogram (MRA) evaluations.