Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects with Persistent or Long Standing Persistent Atrial Fibrillation with Radiofrequency Ablation

The primary effectiveness endpoint is freedom from any documented AF, atrial

flutter, or atrial tachycardia lasting >30 seconds duration through the 12

month follow-up visit in the absence of Class I or III AADs (with the exception

of previously failed AADs at doses not exceeding those previously failed).



The primary safety endpoint is a composite endpoint consisting of any one or

more of the following events if they are adjudicated by the CEC to be serious

adverse events (SAEs) and related to device/procedures as follows:

1. the AtriCure Bipolar System, the AtriClip PRO 1 or PRO2 LAA Exclusion

System, within 30 days of the epicardial surgical ablation procedure, or

2. The epicardial surgical ablation procedure within 30 days following the

epicardial procedure; or

3. The endocardial index procedure (or a repeat endocardial ablation

procedure performed during the blanking period) within 7 days following

an endocardial ablation procedure.



Events except as otherwise specified for a particular condition include:

a. death (regardless of cause)

b. stroke

c. transient ischemic attack (TIA)

d. myocardial infarction (MI)

e. pulmonary or systemic embolism

f. pericarditis resulting in an effusion that leads to hemodynamic compromise

or requires pericardiocentesis, prolongs hospitalization by more than 48 hours,

requires a new hospitalization, or persists for more than 30 days following the

ablation procedure

g. excessive bleeding, defined as one or more of the following:

i. re-operation to control bleeding within 7 days post-epicardial surgical

procedure; or surgery to control bleeding within 7 days post-endocardial

ablation procedure, if related to the endocardial catheter ablation

ii. receipt of >= 2 units of blood transfused in a 24 hour period during the

first 7 days post-epicardial surgical procedure; or within the first 7 days

postendocardial ablation procedure, if related to the device or procedure

iii. conversion to sternotomy or thoracotomy that requires >= 2 units blood to

be transfused, or performed to treat hypotension, cardiac arrest, or repair of

a cardiac injury

h. wound infection at surgical site requiring re-operation for wound debridement

i. atrio-esophageal fistula (from the time of surgical procedure through 12

month follow-up visit)

j. permanent phrenic nerve paralysis, defined as paralysis that remains

unresolved at the 12 month follow-up visit

k. permanent pacemaker implantation that is a direct result of injury to the

specialized conduction system (SA node or AV node) during the epicardial

surgical ablation procedure

l. pulmonary vein (PV) stenosis of >70%, as measured at any time after the

catheter ablation procedure through the 12 month follow-up visit

m. major vascular access complications, including development of a hematoma, an

arteriovenous fistula, or pseudoaneurysm that requires surgical repair or

transfusion, prolong hospital stay, or require a new hospital admission

Seconday safety endpoints

1. Exclusion of the LAA, defined as defined by lack of fluid communication (<3

mm residual communication with LAA and < 10mm residual pocket) between the LA

and LAA. This endpoint will be measured at the 3 Month Visit (Visit 9). The

AtriClip effectiveness population will be utilized for this analysis endpoint.

2. Exclusion of the LAA, defined as lack of fluid communication (<3 mm residual

communication with LAA and <10 mm residual pocket) between the LA and LAA. The

endpoint will be measured intra-procedurally (Visit 2), at the Endocardial EP

Ablation Procedure (Visit 5) and at the 12 Month Visit (visit 11). The AtriClip

effectiveness population will be utilized for this analysis endpoint.

3. Acute procedural success of epicardial surgical procedure, defined as the

percentage of subjects with successful electrical isolation/block of all

pulmonary veins, as well as the *box.*

4. Acute procedural success of endocardial catheter procedure, defined as the

percentage of subjects with successful electrical isolation/block of all

pulmonary veins and the *box*, as well as bi-directional block of the

cavo-tricuspid isthmus.

5. Freedom from Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter without

AAD, defined as no documented event >30 seconds in duration (or for the entire

length of an ECG tracing) with no utilization of AADs beyond the blanking and

AAD optimization periods, except as previously failed without an increase in

dose. This endpoint will be measured through the 12 month, 2, 3, 4, and 5 year

visits (Visits 11-15) via continuous 24-hour ECG monitor.

6. Freedom from Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter

regardless of AAD, defined as no documented event >30 seconds in duration (or

for the entire length of a 30 second ECG tracing) regardless of AAD usage. This

endpoint will be measured through the 12 month, 2, 3, 4, and 5 year visits

(Visits 11-15 via cumulative 24-hour ECG monitoring).

7. Freedom from any documented Atrial Fibrillation, atrial flutter, or atrial

tachycardia lasting >10 minutes in duration through the 12 month follow-up

visit in the absence of Class I or III AADs (with the exception of previously

failed AADs at doses not exceeding those previously

failed).

8. Incidence of stroke or TIA at 12, 24, 36, 48, 60 month visits.

9. Change in Quality of Life, defined as the total AFEQT score measured at the

12 month follow-up visit minus the score at the baseline visit. The score will

be calculated per the AFEQT scoring manual.



All secondary safety endpoints are supplemental and intended to provide a more

complete safety profile for the DEEP procedure. These endpoints will not be

tested for labeling purposes.

1. Major surgical events - This will be a composite safety endpoint within 30

days of the epicardial surgical procedure, as otherwise defined in the primary

safety endpoint.

2. Major catheter events - This will be a composite safety endpoint within 7

days of the endocardial catheter procedure, as otherwise defined in the primary

safety endpoint.

3. 30 day surgical SAEs - This will include all SAEs that occur within 30 days

of the epicardial surgical procedure and that are adjudicated to be related to

the device or to the procedure.

4. 12 month DEEP SAEs - This will include all SAEs through the 12 month

follow-up visit that are adjudicated to be related to an AtriCure device or to

either stage of the DEEP procedure.

5. Unresolved SAEs - This will include all SAEs through the 12 month follow-up

visit that are adjudicated to be related to an AtriCure device or to either

stage of the DEEP procedure and that are not fully resolved by the 12 months

visit. These events shall include any procedure-related deaths, strokes with

residual disability, unresolved phrenic nerve damage, or other such events that

are adjudicated to have resulted in chronic disability or permanent damage.

6. Any serious adverse event through the 12 month follow-up visit,

regardless of attribution.