A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

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 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 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.

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.