Heart Failure Clinical Trial
Official title:
Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart
failure.
Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation
(TENS). It is applied to strengthen the musculature and improve exercise tolerance and
quality of life.
It is unclear if application of TENS can cause electromagnetic interference (EMI) in
patients with Optimizer® pacemaker systems for improvement of heart failure.
This pilot safety study enrolled 6 patients with chronic heart failure and reduced left
ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for
a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to
the study, and all were in clinically stable condition and willing to participate in this
study.
Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF)
on the right and left musculus trapezius and on both musculi quadriceps femoris. All
patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery
of the Optimizer®-system respectively.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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