Clinical trial NCT04206917: MultiPulse Therapy (MPT) for AF
Official title: A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation Energy Therapy in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation, Paroxysmal
Atrial Fibrillation, Persistent
Atrial Fibrillation
Lead sponsor: Cardialen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
name: Avania
First posted: 2019-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cardialen External Stimulation System (CESS) V1.0
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: To define the safety of MPT for the treatment of atrial fibrillation in subjects
timeFrame: Study procedure and 30 day post procedure
measure: Translation
timeFrame: Study procedure
measure: Translation
timeFrame: Study procedure
measure: Translation
timeFrame: Study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: St. Andrews
state: South Australia
city: Melbourne
country: Australia
facility: Mulgrave Private Hospital
state: Victoria
Study officials:
affiliation: Royal Adelaide Hospital - Adelaide Medical School
name: PRASHANTHAN Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.
citation: Li W, Janardhan AH, Fedorov VV, Sha Q, Schuessler RB, Efimov IR. Low-energy multistage atrial defibrillation therapy terminates atrial fibrillation with less energy than a single shock. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):917-25. doi: 10.1161/CIRCEP.111.965830. Epub 2011 Oct 6.
citation: Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. doi: 10.1016/j.hrthm.2006.03.005. Epub 2006 Mar 10. No abstract available.
citation: Ambrosi CM, Ripplinger CM, Efimov IR, Fedorov VV. Termination of sustained atrial flutter and fibrillation using low-voltage multiple-shock therapy. Heart Rhythm. 2011 Jan;8(1):101-8. doi: 10.1016/j.hrthm.2010.10.018. Epub 2010 Oct 19.