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MultiPulse Therapy (MPT) for AF

NCT04206917 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-14

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Multi Pulse 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.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Avania

    collaborator INDUSTRY

  • Cardialen, Inc.

    lead INDUSTRY

Principal Investigators

  • PRASHANTHAN Sanders, MD · Royal Adelaide Hospital - Adelaide Medical School

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-19
Primary Completion
2022-06-21
Completion
2022-06-21
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206917 on ClinicalTrials.gov