MultiPulse Therapy (MPT) for AF
Primary Purpose
Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent, Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Multi Pulse Therapy
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation, Paroxysmal
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 globally accepted risk stratification (CHA2DS2-VASc score) and the Principal Investigator
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<20%
- NYHA Class 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)
- No 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 investigators
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
- Any other condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Sites / Locations
- The Prince Charles Hospital
- Gold Coast University Hospital
- Greenslopes Private Hospital
- Royal Adelaide Hospital
- St. Andrews
- Mulgrave Private Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi Pulse Therapy
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
To define the safety of MPT for the treatment of atrial fibrillation in subjects
Adverse Events from procedure and 30 day follow up.
Translation
Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
Translation
Determine MPT parameters relationships at which MPT terminates AF
Translation
Determine rate of conversion from AF to NSR after MPT delivery
Secondary Outcome Measures
Full Information
NCT ID
NCT04206917
First Posted
October 23, 2019
Last Updated
October 7, 2022
Sponsor
Cardialen, Inc.
Collaborators
Iqvia Pty Ltd, Avania
1. Study Identification
Unique Protocol Identification Number
NCT04206917
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor ceasing operations
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardialen, Inc.
Collaborators
Iqvia Pty Ltd, Avania
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
Product Manufactured in and Exported from the U.S.
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
Cardialen External Stimulation System (CESS) V1.0
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi Pulse Therapy
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
Other Intervention Name(s)
Unpinning Termination Therapy, Multi-stage therapy, Multi-stage electrotherapy, MultiPulse Therapy
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.
Primary Outcome Measure Information:
Title
To define the safety of MPT for the treatment of atrial fibrillation in subjects
Description
Adverse Events from procedure and 30 day follow up.
Time Frame
Study procedure and 30 day post procedure
Title
Translation
Description
Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
Time Frame
Study procedure
Title
Translation
Description
Determine MPT parameters relationships at which MPT terminates AF
Time Frame
Study procedure
Title
Translation
Description
Determine rate of conversion from AF to NSR after MPT delivery
Time Frame
Study procedure
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 globally accepted risk stratification (CHA2DS2-VASc score) and the Principal Investigator
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<20%
NYHA Class 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)
No 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 investigators
History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
Any other condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PRASHANTHAN Sanders, MD
Organizational Affiliation
Royal Adelaide Hospital - Adelaide Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Gold Coast University Hospital
City
Gold Coast
State/Province
Queensland
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St. Andrews
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Mulgrave Private Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3170
Country
Australia
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
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