GekoTM Pacemaker Interaction Study
Research type
Research Study
Full title
A prospective trial to determine if it is safe to use the gekoTM neuromuscular electrostimulation device in a pacemaker population.
IRAS ID
283281
Contact name
Zaheer Yousef
Contact email
Sponsor organisation
Firstkind Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Summary of Research
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.Summary of Results
A total of 28 patients were recruited into the trial. Patients were allocated their study arm on the basis of the type of pacemaker implanted (11-single chamber, 10-dual chamber, 7-bi-ventricular).
In total, 2372 energy pulses were delivered by gekoTM devices to patients with implanted on-demand pacemakers. Pulses ranged across the energy output available for the device and were delivered to trial subjects. Test intracardiac electrogram strips were recorded and printed for each patient. These were repeated four times for each subject so that all sensing modalities (unipolar and bipolar) and pacing (paced cardiac rhythm) and non-pacing (intrinsic cardia rhythm) functionality could be assessed. In all cases, the site investigator assessed the intracardiac pacemaker electrogram to determine if any energy pulses from the gekoTM device had been sensed or recorded by the pacemakers; zero (0) gekoTM pulses were sensed by pacemakers during this investigation.
In conclusion, there is no evidence to support the hypothesis that cardiac demand pacemakers interact or sense the energy pulse of the gekoTM device. As a result of this investigation there are no safety concerns related to the use of gekoTM with on-demand cardiac pacemakers. There were no adverse events and no device deficiencies recorded. All trial participants completed the trial successfully.REC name
Wales REC 4
REC reference
20/WA/0166
Date of REC Opinion
1 Jul 2020
REC opinion
Further Information Favourable Opinion