Clinical Trials

Inclusion Criteria:

1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent
symptomatic AF, or intolerable side effects due to AAD.

2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:

1. Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously
or with intervention within 7 days of onset, documented by the following:

1. physician's note indicating at least 2 symptomatic paroxysmal AF episodes
occurring within 6 months prior to enrollment; and

2. at least 1 ECG documented AF episode from any form of rhythm monitoring
within 12 months prior to enrollment OR

2. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7
days and less than 1 year, documented by the following:

1. physician's note indicating at least 1 symptomatic persistent AF episode
occurring within 6 months prior to enrollment; and

2. any 24-hour continuous ECG recording documenting continuous AF within 6
months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring
taken at least 7 days apart, both showing continuous AF within 6 months
prior to enrollment

3. Age 18 through 80 years old (or older than 18 if required by local law)

Exclusion Criteria:

1. Long-standing persistent AF (continuous AF that is sustained >12 months)

2. Left atrial diameter > 5.0 cm (anteroposterior)

3. Prior left atrial ablation or surgical procedure (including left atrial appendage
closures)

4. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular
pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable
cardiac defibrillator (with or without biventricular pacing function) for any time
during the follow-up period

5. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the
ablation procedure

6. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable
cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or
without biventricular pacing function)

7. Presence of any pulmonary vein stents

8. Presence of any pre-existing pulmonary vein stenosis

9. Pre-existing hemidiaphragmatic paralysis

10. Presence of any cardiac valve prosthesis

11. Moderate to severe mitral valve stenosis

12. More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)

13. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting
which occurred during the 3-month interval preceding the consent date

14. Unstable angina

15. NYHA Class III or IV congestive heart failure or documented left ventricular ejection
fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g.
TTE)

16. Primary pulmonary hypertension

17. Rheumatic heart disease

18. Thrombocytosis, thrombocytopenia

19. Any condition contraindicating chronic anticoagulation

20. Active systemic infection

21. Hypertrophic cardiomyopathy

22. Known reversible causes of AF, including but not limited to uncontrolled
hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity

23. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month
interval preceding the consent date

24. History of thromboembolic event within the past 6 months or evidence of intracardiac
thrombus at the time of the procedure

25. Any woman known to be pregnant or breastfeeding, or any woman of childbearing
potential who is not on a reliable form of birth regulation method or abstinence

26. Patient with life expectancy that makes it unlikely 12 months of follow-up will be
completed

27. Current or anticipated participation in any other clinical trial of a drug, device or
biologic during the duration of the study not pre-approved by Medtronic

28. Known allergies or hypersensitivities to adhesives

29. Unwilling or unable to comply fully with study procedures and follow-up

30. Unable to provide own informed consent

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.