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MultiPulse Therapy (MPT) for AF (US)

NCT05055921 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-10

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 as delivered from the Cardialen External Stimulation System

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

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Cardialen, Inc.

    lead INDUSTRY

Principal Investigators

  • John D Hummel, MD · Ohio State University (OSU) Wexner Medical Center

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
2022-02-28
Primary Completion
2022-10-01
Completion
2022-10-01
FDA Device
Yes

Countries

  • United States

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 NCT05055921 on ClinicalTrials.gov