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Atrial FibrillationNCT05055921

MultiPulse Therapy (MPT) for AF (US)

A study testing Multi Pulse Therapy as delivered from the Cardialen External Stimulation System in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Cardialen, Inc. at 2 sites in United States.

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 as delivered from the Cardialen External Stimulation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
28 Feb 2022to 1 Oct 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 the Principal Investigator

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Ohio State University

    Columbus, Ohio, 43210

  • Minneapolis Veterans Administration Hospital

    Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation (US)

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 as delivered from the Cardialen External Stimulation System
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 Therapy as delivered from the Cardialen External Stimulation SystemDevice

    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
Study groups in NCT05055921
Study groupRoleWhat they receive
Multi Pulse Therapy as delivered from the Cardialen External Stimulation SystemExperimentalSubjects 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 as delivered from the Cardialen External Stimulation System

What is being measured

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

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

    Reported Adverse Events following MPT delivery

    Measured: Acutely at the time of the study procedure

  2. The safety of MPT for the treatment of atrial fibrillation in subjects

    Reported Adverse Events following MPT delivery

    Measured: At 30 day post procedure

  3. Enhanced ability of MPT to stop atrial fibrillation

    Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112)

    Measured: Acutely following MPT delivery

  4. Ability of MPT to stop atrial fibrillation

    Determine rate of conversion from AF to NSR

    Measured: Acutely following MPT delivery

Timeline

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

  1. First posted24 Sep 2021
  2. Study start28 Feb 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Why it stopped: Sponsor ceased 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
Multi-Pulse Therapy as delivered from the Cardialen External Stimulation System (CESS)
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05055921
Sponsor's protocol ID
CL007 (US)
Status last verified
Oct 2022
First submitted
17 Aug 2021
Last updated
10 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 as delivered from the Cardialen External Stimulation System in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Cardialen, Inc. at 2 sites in United States.

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 10 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 2 sites in United States. 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 ceased 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?

The safety of MPT for the treatment of atrial fibrillation in subjects (time frame: Acutely at the time of the study 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 NCT05055921, 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 10 Oct 2022.

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MultiPulse Therapy (MPT) for AF (US) (NCT05055921) | AzTrials