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Atrial Fibrillation, ParoxysmalNCT04206917

MultiPulse Therapy (MPT) for AF

A study testing Multi Pulse Therapy in people with Atrial Fibrillation, Paroxysmal and Atrial Fibrillation, Persistent, run by Cardialen, Inc. at 6 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
What is being tested?
Multi Pulse Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesAustralia
Study dates
19 Mar 2020to 21 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St. Andrews

    Adelaide, South Australia

  • The Prince Charles Hospital

    Chermside, Queensland

  • Gold Coast University Hospital

    Gold Coast, Queensland

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Mulgrave Private Hospital

    Melbourne, Victoria, 3170

Other trials in Australia

About this study

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

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

Read the 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.

Being tested
Multi Pulse Therapy
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi Pulse TherapyDevice

    Also called Unpinning Termination Therapy, Multi-stage therapy, Multi-stage electrotherapy, MultiPulse Therapy

    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.

Study groups in NCT04206917
Study groupRoleWhat they receive
Multi Pulse TherapyExperimentalSubjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
Receives: Device: Multi Pulse Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To define the safety of MPT for the treatment of atrial fibrillation in subjects

    Adverse Events from procedure and 30 day follow up.

    Measured: Study procedure and 30 day post procedure

  2. Translation

    Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)

    Measured: Study procedure

  3. Translation

    Determine MPT parameters relationships at which MPT terminates AF

    Measured: Study procedure

  4. Translation

    Determine rate of conversion from AF to NSR after MPT delivery

    Measured: Study procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2019
  2. Study start19 Mar 2020
  3. Primary completion21 Jun 2022
  4. Study completion21 Jun 2022

Why it stopped: Sponsor ceasing operations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Cardialen External Stimulation System (CESS) V1.0
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04206917
Sponsor's protocol ID
CL007
Status last verified
Oct 2022
First submitted
23 Oct 2019
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 24076284

  • 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.

    PubMed 21980076

  • 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.

    PubMed 16945810

  • 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.

    PubMed 20969974

Questions about this trial

What is this clinical trial studying?

A study testing Multi Pulse Therapy in people with Atrial Fibrillation, Paroxysmal and Atrial Fibrillation, Persistent, run by Cardialen, Inc. at 6 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor ceasing operations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To define the safety of MPT for the treatment of atrial fibrillation in subjects (time frame: Study procedure and 30 day post procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206917, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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