MultiPulse Therapy (MPT) for AF (US)

Atrial Fibrillation Clinical Trial

Official title:

A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation (US)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05055921
• Other study ID #: CL007 (US)
• Status: Terminated
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Cardialen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

The subject must not meet any of the following 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<35%

11. NYHA Class III or 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
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. Other Names: Unpinning Termination Therapy Multi-stage therapy Multi-stage electrotherapy MultiPulse Therapy

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Minneapolis Veterans Administration Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Cardialen, Inc.	Iqvia Pty Ltd

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. Epub 2006 Mar 10. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of MPT for the treatment of atrial fibrillation in subjects	Reported Adverse Events following MPT delivery	Acutely at the time of the study procedure
Primary	The safety of MPT for the treatment of atrial fibrillation in subjects	Reported Adverse Events following MPT delivery	At 30 day post procedure
Primary	Enhanced ability of MPT to stop atrial fibrillation	Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112)	Acutely following MPT delivery
Primary	Ability of MPT to stop atrial fibrillation	Determine rate of conversion from AF to NSR	Acutely following MPT delivery