MultiPulse Therapy (MPT) for AF (US)

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

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

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Multi Pulse Therapy as delivered from the Cardialen External Stimulation System

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis Veterans Administration Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Multi Pulse Therapy as delivered from the Cardialen External Stimulation System; Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The safety of MPT for the treatment of atrial fibrillation in subjects	Reported Adverse Events following MPT delivery	At 30 day post procedure
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
Ability of MPT to stop atrial fibrillation	Determine rate of conversion from AF to NSR	Acutely following MPT delivery

Collaborators and Investigators

• Sponsor: Cardialen, Inc.
• Collaborators: IQVIA Pty Ltd
• Investigators: Principal Investigator: John D Hummel, MD, Ohio State University (OSU) Wexner Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2022
• Primary Completion (ACTUAL): October 1, 2022
• Study Completion (ACTUAL): October 1, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (ACTUAL): September 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL007 (US)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes