Study of gekoTM Interaction With Cardiac Pacemakers
A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.
There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
Study Overview
Status
Intervention / Treatment
Detailed Description
CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'.
Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.
There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.
The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales
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Dudley, United Kingdom, DY1 2HQ
- The Dudley Group NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of geko™ device application.
- Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion Criteria:
- Pregnancy or breast feeding.
- Use of any concurrent use of a neuro-modulation device.
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
- Participation in any other clinical study that may interfere with the outcome of either study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Main
gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference.
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Assess if cardiac pacemakers detect geko™ electrical output pulse.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period.
Time Frame: One day - single follow-up.
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Interference with pacemaker function.
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One day - single follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The secondary endpoints are the incidence of adverse events (AEs), incidence of serious AEs (SAEs), incidence of study treatment related AEs, and the incidence of investigational device related AEs.
Time Frame: One day-single follow-up.
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Incidence of adverse and serious adverse events.
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One day-single follow-up.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zaheer Yousef, MD, University Hospital of Wales, Cardiff
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FSK-CVD-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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