Study of gekoTM Interaction With Cardiac Pacemakers

NCT04391257 | Completed DMC

• 1 other identifier: FSK-CVD-003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Wound Heal; Edema Leg; Cardiac Pacemaker Electrical Interference

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period.

  Interference with pacemaker function.

  One day - single follow-up.

Secondary Outcomes (1)

• 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.

  One day-single follow-up.

Study Arms (1)

Main

OTHER

gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference.

Device: geko™

Interventions

geko™ DEVICE

Assess if cardiac pacemakers detect geko™ electrical output pulse.

Main

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (2)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

The Dudley Group NHS Foundation Trust

Dudley, DY1 2HQ, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zaheer Yousef, MD

  University Hospital of Wales, Cardiff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 18, 2020
• Study Start: December 4, 2020
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

GB (2)