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Unpinning Termination Therapy for VT/VF

NCT03871231 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-08-11

No results posted yet for this study

Summary

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.

Conditions

  • Ventricular Tachycardia
  • Ventricular Fibrillation

Interventions

DEVICE

Unpinning Termination Therapy

The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. 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

  • Genae

    collaborator INDUSTRY

  • Five Corners

    collaborator UNKNOWN

  • Cardialen, Inc.

    lead INDUSTRY

Principal Investigators

  • Harris Haqqani, MD · The Prince Charles Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-07-15
Completion
2021-07-15
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03871231 on ClinicalTrials.gov