MultiPulse Therapy (MPT) for AF (US)
Primary Purpose
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Male or female between 18 and 80 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation
- 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:
- Life expectancy of 1 year or less
- AF due to reversible causes (e.g., hyperthyroidism, valve disease)
- History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
- Currently in AF for more than 3 months continuously
- Chronic, long-standing persistent, or permanent atrial fibrillation
- Allergy or contraindication to anticoagulation therapy
- Presence of intracardiac thrombus (confirmed with TEE or ICE)
- Existing Left Atrial Appendage closure device
- Severely Dilated Left Atrium >5cm
- LVEF<35%
- NYHA Class III or IV heart failure at the time of enrollment
- History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
- Known hyper-coagulable state that increases risk of thrombus
- History of myocardial infarction or coronary revascularization within the preceding 3 months.
- History of sustained ventricular arrhythmia or cardiac arrest
- Presence of chronically implanted lead in the CS
- Presence of ventricular assist device, including intra-aortic balloon pump
- Documented bradycardia (<40 BPM) at the time of the study
- Morbid obesity: BMI>39 kg/m2
- Presence of any prosthetic cardiac valve
- History of significant tricuspid valvular disease requiring surgery
- Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
- Cognitive or mental health status that would interfere with study participation and proper informed consent
- 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
- Pregnancy confirmed by test within 7 days of procedure.
- Inability to pass catheters to heart due to vascular limitations
- 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)
- Active endocarditis
- Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
- History of hemodynamic compromise due to valvular heart disease
- Unstable CAD as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
Sites / Locations
- Minneapolis Veterans Administration Hospital
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
Arm Description
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
Outcomes
Primary Outcome Measures
The safety of MPT for the treatment of atrial fibrillation in subjects
Reported Adverse Events following MPT delivery
The safety of MPT for the treatment of atrial fibrillation in subjects
Reported Adverse Events following MPT delivery
Enhanced ability of MPT to stop atrial fibrillation
Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112)
Ability of MPT to stop atrial fibrillation
Determine rate of conversion from AF to NSR
Secondary Outcome Measures
Full Information
NCT ID
NCT05055921
First Posted
August 17, 2021
Last Updated
October 7, 2022
Sponsor
Cardialen, Inc.
Collaborators
Iqvia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05055921
Brief Title
MultiPulse Therapy (MPT) for AF (US)
Official Title
A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation (US)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor ceased operations
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardialen, Inc.
Collaborators
Iqvia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
In Atrial Fibrillation at time of procedure (Clinical AF)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-Pulse Therapy as delivered from the Cardialen External Stimulation System (CESS)
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
Arm Type
Experimental
Arm Description
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
Intervention Type
Device
Intervention Name(s)
Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
Intervention Description
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
Primary Outcome Measure Information:
Title
The safety of MPT for the treatment of atrial fibrillation in subjects
Description
Reported Adverse Events following MPT delivery
Time Frame
Acutely at the time of the study procedure
Title
The safety of MPT for the treatment of atrial fibrillation in subjects
Description
Reported Adverse Events following MPT delivery
Time Frame
At 30 day post procedure
Title
Enhanced ability of MPT to stop atrial fibrillation
Description
Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112)
Time Frame
Acutely following MPT delivery
Title
Ability of MPT to stop atrial fibrillation
Description
Determine rate of conversion from AF to NSR
Time Frame
Acutely following MPT delivery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between 18 and 80 years of age
Willing and able to comply with the study protocol, provide a written informed consent
Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation
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:
Life expectancy of 1 year or less
AF due to reversible causes (e.g., hyperthyroidism, valve disease)
History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
Currently in AF for more than 3 months continuously
Chronic, long-standing persistent, or permanent atrial fibrillation
Allergy or contraindication to anticoagulation therapy
Presence of intracardiac thrombus (confirmed with TEE or ICE)
Existing Left Atrial Appendage closure device
Severely Dilated Left Atrium >5cm
LVEF<35%
NYHA Class III or IV heart failure at the time of enrollment
History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
Known hyper-coagulable state that increases risk of thrombus
History of myocardial infarction or coronary revascularization within the preceding 3 months.
History of sustained ventricular arrhythmia or cardiac arrest
Presence of chronically implanted lead in the CS
Presence of ventricular assist device, including intra-aortic balloon pump
Documented bradycardia (<40 BPM) at the time of the study
Morbid obesity: BMI>39 kg/m2
Presence of any prosthetic cardiac valve
History of significant tricuspid valvular disease requiring surgery
Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
Cognitive or mental health status that would interfere with study participation and proper informed consent
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
Pregnancy confirmed by test within 7 days of procedure.
Inability to pass catheters to heart due to vascular limitations
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)
Active endocarditis
Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
History of hemodynamic compromise due to valvular heart disease
Unstable CAD as determined by the investigator
Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Hummel, MD
Organizational Affiliation
Ohio State University (OSU) Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Veterans Administration Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24076284
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.
Results Reference
background
PubMed Identifier
21980076
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.
Results Reference
background
PubMed Identifier
16945810
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.
Results Reference
background
PubMed Identifier
20969974
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.
Results Reference
background
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MultiPulse Therapy (MPT) for AF (US)
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