Atrial Fibrillation, Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent
Conditions
Brief summary
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
Detailed description
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. Subjects will be split into 2 cohorts depending on status at time of procedure. 1. In Atrial Fibrillation at time of procedure (Clinical AF) 2. In Normal Sinus Rhythm at time of procedure Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.
Interventions
DEVICEMulti Pulse Therapy
The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen MultiPulse Therapy (MPT). The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
Sponsors
Iqvia Pty Ltd
Avania
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Cardialen External Stimulation System (CESS) V1.0
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 globally accepted risk stratification (CHA2DS2-VASc score) and 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. No 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 investigators 33. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis 34. Any other condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To define the safety of MPT for the treatment of atrial fibrillation in subjects | Study procedure and 30 day post procedure | Adverse Events from procedure and 30 day follow up. |
| Translation | Study procedure | Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112) |
Countries
Australia
Outcome results
None listed