- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206917
MultiPulse Therapy (MPT) for AF
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Queensland
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Chermside, Queensland, Australia
- The Prince Charles Hospital
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Gold Coast, Queensland, Australia
- Gold Coast University Hospital
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Greenslopes, Queensland, Australia, 4120
- Greenslopes Private Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Adelaide, South Australia, Australia
- St. Andrews
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Victoria
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Melbourne, Victoria, Australia, 3170
- Mulgrave Private Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Multi Pulse Therapy
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To define the safety of MPT for the treatment of atrial fibrillation in subjects
Time Frame: Study procedure and 30 day post procedure
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Adverse Events from procedure and 30 day follow up.
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Study procedure and 30 day post procedure
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Translation
Time Frame: Study procedure
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Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
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Study procedure
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Translation
Time Frame: Study procedure
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Determine MPT parameters relationships at which MPT terminates AF
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Study procedure
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Translation
Time Frame: Study procedure
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Determine rate of conversion from AF to NSR after MPT delivery
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Study procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: PRASHANTHAN Sanders, MD, Royal Adelaide Hospital - Adelaide Medical School
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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