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Electrical Stimulation

Multi Pulse Therapy as delivered from the Cardialen External Stimulation System for Atrial Fibrillation

N/A
Waitlist Available
Led By John D Hummel, MD
Research Sponsored by Cardialen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up acutely following mpt delivery
Awards & highlights

Study Summary

This trial assesses the safety and feasibility of a new electrical stimulation waveform sequence to treat atrial fibrillation.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 day post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 day post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability of MPT to stop atrial fibrillation
Enhanced ability of MPT to stop atrial fibrillation
The safety of MPT for the treatment of atrial fibrillation in subjects

Trial Design

1Treatment groups
Experimental Treatment
Group I: Multi Pulse Therapy as delivered from the Cardialen External Stimulation SystemExperimental Treatment1 Intervention
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.

Find a Location

Who is running the clinical trial?

Cardialen, Inc.Lead Sponsor
5 Previous Clinical Trials
97 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
83 Patients Enrolled for Atrial Fibrillation
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
170,002 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
2,051 Patients Enrolled for Atrial Fibrillation
John D Hummel, MDPrincipal InvestigatorOhio State University (OSU) Wexner Medical Center
1 Previous Clinical Trials
2,014 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Heart RhythmJournal
Virtual Electrode Hypothesis of Defibrillation
Efimov, Igor, and Crystal M. Ripplinger. 2006. “Virtual Electrode Hypothesis of Defibrillation”. Heart Rhythm. Elsevier BV. doi:10.1016/j.hrthm.2006.03.005.
Heart RhythmJournal
Termination of Sustained Atrial Flutter and Fibrillation Using Low-voltage Multiple-shock Therapy
Ambrosi, Christina M., Crystal M. Ripplinger, Igor R. Efimov, and Vadim V. Fedorov. 2011. “Termination of Sustained Atrial Flutter and Fibrillation Using Low-voltage Multiple-shock Therapy”. Heart Rhythm. Elsevier BV. doi:10.1016/j.hrthm.2010.10.018.
Circulation: Arrhythmia and ElectrophysiologyJournal
Low-energy Multistage Atrial Defibrillation Therapy Terminates Atrial Fibrillation with Less Energy Than a Single Shock
Li, Wenwen, Ajit H. Janardhan, Vadim V. Fedorov, Qun Sha, Richard B. Schuessler, and Igor R. Efimov. 2011. “Low-energy Multistage Atrial Defibrillation Therapy Terminates Atrial Fibrillation with Less Energy Than a Single Shock”. Circulation: Arrhythmia and Electrophysiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circep.111.965830.
Journal of the American College of CardiologyJournal
Multistage Electrotherapy Delivered Through Chronically-implanted Leads Terminates Atrial Fibrillation with Lower Energy Than a Single Biphasic Shock
Janardhan, Ajit H., Sarah R. Gutbrod, Wenwen Li, Di Lang, Richard B. Schuessler, and Igor R. Efimov. 2014. “Multistage Electrotherapy Delivered Through Chronically-implanted Leads Terminates Atrial Fibrillation with Lower Energy Than a Single Biphasic Shock”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.07.098.
~2 spots leftby Apr 2025
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