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Sponsor ceasing operations
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
| Avania | INDUSTRY |
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Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi Pulse Therapy | Experimental | Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi Pulse Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To define the safety of MPT for the treatment of atrial fibrillation in subjects | Adverse Events from procedure and 30 day follow up. | Study procedure and 30 day post procedure |
| Translation | Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112) | Study procedure |
| Translation | Determine MPT parameters relationships at which MPT terminates AF | Study procedure |
| Translation | Determine rate of conversion from AF to NSR after MPT delivery | Study procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PRASHANTHAN Sanders, MD | Royal Adelaide Hospital - Adelaide Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Chermside | Queensland | Australia | |||
| Gold Coast University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24076284 | Background | 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. | |
| 21980076 | Background |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Cardialen External Stimulation System (CESS) V1.0
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|
|
| Gold Coast |
| Queensland |
| Australia |
| Greenslopes Private Hospital | Greenslopes | Queensland | 4120 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| St. Andrews | Adelaide | South Australia | Australia |
| Mulgrave Private Hospital | Melbourne | Victoria | 3170 | Australia |
| 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. |
| 16945810 | Background | 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. |
| 20969974 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |