POLARx Cardiac Cryoablation System Post Market Clinical Follow-up study

Primary Saferty Endpoint:

Safety event free rate at 12 months post-index procedure.

Primary safety events will consist of a composite of the following

procedure-related and device-related adverse events.

Acute primary safety endpoint events, events occurring up to 7 days postindex

procedure or hospital discharge, whichever is later, include:

• Death

• Myocardial infarction (MI)

• Persistent gastroparesis/injury to vagus nerve

• Transient ischemic attack (TIA)

• Stroke/Cerebrovascular accident (CVA)

• Thromboembolism/Air embolism*

• Cardiac tamponade/perforation

• Pneumothorax

• Serious vascular access complications**

• Pulmonary edema/heart failure

• AV block not attributable to medication effect or vasovagal reaction.

* Thromboembolic or /air embolic events collected in the study refer to any

occlusion of

blood vessel(s) that results in clinical symptoms

** Defined as prolongation of hospitalization, requirement of surgical

intervention or

blood transfusion

Chronic primary safety endpoint events, events occurring through 12

months post-index procedure, include:

• Atrial esophageal fistula

• Pulmonary vein stenosis (>= 70% reduction of diameter)

• Symptomatic pericardial effusion

• Persistent Phrenic nerve injury***

***A non-recovered phrenic nerve injury at 12 months post-index procedure will

count

as a chronic primary endpoint. The study will collect information on phrenic

nerve palsy

observed before the end of the index procedure and, in case it occurred, will

track

information for potential recovery during the study visits.



Primary Effectiveness Endpoint:

Failure free rate at 12 months post-index procedure.

Failure defined as:

• Failure to achieve acute procedural success* in the index procedure;

• More than one repeat procedure during the blanking period (within 90 days

post-index procedure);

• Documented atrial fibrillation, or new onset of atrial flutter or atrial

tachycardia event (>= 30 seconds in duration or from a 10 second 12-lead ECG)

between days 91 and days 365 post-index procedure **;

• Any of the following interventions for atrial fibrillation, or new onset of

atrial flutter or atrial tachycardia between days 91 and days 365 post-index

procedure:

• Repeat procedure;

• Electrical and/or pharmacological cardioversion for AF/AFL/AT;

• Prescribed a higher dose of any AAD*** documented at baseline or a new AAD***

not documented at baseline.

* Acute procedural success is defined as isolation of the all pulmonary veins

or anatomical equivalents achieved with the Cryoablation Catheter at the end of

the index procedure and as demonstrated at minimum by entrance block using the

Cryo Mapping Catheter (Other techniques of assessment are per investigator*s

discretion).

** Subjects will be monitored for recurrences of the arrhythmias by means of

clinical visits, ECG and 24-hour Holter monitoring.

*** AADs for endpoint will consist of all Class I/III and any Class II/IV

medications taken for control of AF/AT/AFL recurrence

Documentation and rate of acute procedural success, defined as pulmonary vein

isolation achieved with the Cryoablation System. Electrical isolation of a PV

is demonstrated at minimum by entrance block using the Cryo Mapping Catheter

(Other techniques of assessment are per investigator*sdiscretion).

Information on isolation method used per site standard of care will be

collected with a minimum by entrance block in all PVs or anatomical

equivalents. Additional data, if available, will be collected on Exit Block or

Conduction Block verification using 3D mapping.



Additional endpoints:

Additional endpoints and analyses include, but are not limited to:

• Procedure times: LA dwell time*, total ablation time, number of cryo

applications per vein, time to thaw, total fluoroscopy time and total procedure

time;

• Time-To-Isolation per ablation application, if available;

• Freedom from recurrence of individual types of atrial arrhythmias (AF, AFL,

AT) between days 91 and days 365 post-index procedure;

• Analysis of ablation techniques (i.e. segmental approach to left common

trunk, additional linear ablations, etc.);

• Analysis of different anaesthesia techniques (General anaesthesia with or

without intubation versus sedation);

• Freedom from recurrence in subjects with non-common anatomical configurations

of PV (e.g. left common trunk);

• Freedom from primary effectiveness failure evaluated in subgroups of subjects

(termination of AAD versus continuation of AAD after blanking period);

• For the subgroup of subjects undergoing 3D mapping with the Boston Scientific

mapping Rhythmia system and performing a post-procedural map, map information

will be collected to determine lesion locations;

• For subjects that will undergo repeat ablation during the course of the

clinical follow-up, anatomical location of ablations gaps will be assessed.

* LA dwell time is defined as time from the Cryoablation Catheter introduced in

the left atrium (LA) to the last time of Cryoablation Catheter exiting the LA.



Additional ancillary analyses on specific subgroup of subjects, may be

presented.

These analyses will include but not limited to the following:

• Age (<60 versus >= 60 years);

• Gender (Male versus Female).