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A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients with Atrial Fibrillation

The number of patients recruited by Canberra Heart Rhythm: not enrolling yet

The purpose of this study is to assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

This is a prospective non-randomized feasibility study involving acute testing of MPT in subjects with paroxysmal and persistent AF during clinically indicated atrial fibrillation catheter ablation procedure.

Up to 50 participants will be recruited for this study in the USA and Australia.

Primary objectives:

1. To define the safety of MPT for the treatment of atrial fibrillation in subjects with paroxysmal and short-duration persistent AF.

2. Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001).

3. Determine MPT parameters relationships at which MPT terminates AF.

4. Determine rate of conversion from AF to NSR after MPT delivery.

Inclusion Criteria

  1. Male or female between 18 and 80 years of age
  2. Willing and able to comply with the study protocol, provide a written informed consent
  3. Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation
  4. Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator

Exclusion Criteria

  1. Life expectancy of 1 year or less
  2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)
  3. History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
  4. Currently in AF for more than 3 months continuously
  5. Chronic, long-standing persistent, or permanent atrial fibrillation
  6. Allergy or contraindication to anticoagulation therapy
  7. Presence of intracardiac thrombus (confirmed with TEE or ICE)
  8. Existing Left Atrial Appendage closure device
  9. Severely Dilated Left Atrium >5cm
  10. LVEF<20%
  11. NYHA Class IV heart failure at the time of enrollment
  12. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
  13. Known hyper-coagulable state that increases risk of thrombus
  14. History of myocardial infarction or coronary revascularization within the preceding 3 months.
  15. History of sustained ventricular arrhythmia or cardiac arrest
  16. Presence of chronically implanted lead in the CS
  17. Presence of ventricular assist device, including intra-aortic balloon pump
  18. Documented bradycardia (<40 BPM) at the time of the study
  19. Morbid obesity: BMI>39 kg/m2
  20. Presence of any prosthetic cardiac valve
  21. History of significant tricuspid valvular disease requiring surgery
  22. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
  23. Cognitive or mental health status that would interfere with study participation and proper informed consent
  24. Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator’s discretion
  25. Pregnancy confirmed by test within 7 days of procedure.
  26. Inability to pass catheters to heart due to vascular limitations
  27. Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
  28. Active endocarditis
  29. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
  30. History of hemodynamic compromise due to valvular heart disease
  31. Unstable CAD as determined by the investigator
  32. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
  33. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis