Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation

Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation

The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).

This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated.

Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.

Inclusion Criteria:

1. Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:

   Paroxysmal AF (Phase A participants)

   1. Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND
   2. At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment

   Persistent AF (Phase A, B, and C participants)

   1. Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND
   2. Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR
   3. Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR
   4. History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment

2. Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD

3. Age 18 through 75 years-old on the day of enrollment

4. Patient is indicated for an ablation procedure according to society guidelines or study site practice

5. Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study

Exclusion Criteria:

1. Long-standing persistent AF (continuous AF sustained > 1 year)

2. AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes

3. Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)

4. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation

5. Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation procedure

6. Patient cannot be removed from AADs for reasons other than AF, which includes participants with Wolff-Parkinson-White (WPW) Syndrome and participants with a history of ventricular tachycardia (VT)

7. Presence of any IVC filters

8. Presence of an interatrial baffle or patch

9. Presence of any pulmonary vein stents

10. Pre-existing pulmonary vein stenosis

11. Pre-existing hemidiaphragmatic paralysis

12. Atrial or ventricular septal defect closure

13. Atrial myxoma

14. Presence of any mechanical or biologic prosthetic heart valve

15. Hemodynamically significant valvular disease as determined by the Investigator

16. History of pericarditis

17. History of Rheumatic heart disease

18. History of thromboembolic event within 6 months prior to Index Ablation Procedure or evidence of intracardiac thrombus at time of the Index Ablation Procedure

19. Any of the following events within 3 months prior to the Index Ablation Procedure:

    • Myocardial infarction
    • Unstable angina
    • Percutaneous coronary intervention
    • Heart surgery including coronary artery bypass grafting
    • Heart failure hospitalization
    • Cerebral ischemic event (stroke or transient ischemic attack (TIA))
    • Clinically significant bleeding requiring surgical intervention
    • Pericardial effusion
    • Ventriculotomy or atriotomy

20. New York Heart Association (NYHA) Class IV congestive heart failure

21. Documented left ventricular ejection fraction (LVEF) ≤35% measured by acceptable cardiac testing (e.g., TTE, cardiac CT, etc.) within 6 months prior to enrollment

22. Hypertrophic cardiomyopathy

23. Primary pulmonary hypertension

24. Significant or symptomatic hypotension

25. Thrombocytosis, thrombocytopenia

26. Contraindication to, or unwillingness to use, systemic anticoagulation

27. Patient contraindicated for CT or MRI

28. Sensitivity to contrast media not controlled by premedication

29. Women known to be pregnant or breastfeeding, or any women of childbearing potential who are not on a reliable form of birth regulation method or abstinence

30. Patient is participating in any other potentially confounding research

31. Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or is interpretation, including but not limited to:

    • Solid organ or hematologic transplant, or currently being evaluated for organ transplant
    • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
    • Chronic renal insufficiency with eGFR <50 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
    • Active malignancy or history of treated cancer within 24 months prior to enrollment
    • History of severe esophageal ulcers, strictures, esophagitis, esophageal structural abnormality, and uncontrolled/untreated gastroesophageal reflux disease (GERD)
    • Active systemic infection
    • Clinically significant psychological condition that, in the Investigator's opinion, would prohibit the participant's ability to meet the protocol requirements
    • Predicted life expectancy <1 year