TENS in Optimizer(R) Patients

Heart Failure Clinical Trial

Official title:

Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692690
• Other study ID #: 1067_2015
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2016
• Last updated: February 22, 2016
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• >18 years, with implantation of the Optimizer ® >6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.

Exclusion Criteria:

• Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Stimulette r4x

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patients with CCM-system are assessed for EMI during TENS-application	Electromagnetic interference can cause artificial sensing in pacemaker or ICD system. These artefacts may have the effect of suppressing the pacemaker pulses sensing of tachycardia in ICD.; The patients will be exposed to electrical stimulations, which will be of different forces on the neck and the upper thigh with r4x. These impulses and the effects will be noted down. It will be investigated if there is an interference with the optimizer ® depending on the different sites of the electrical stimulations and the different impulse forces.; Many patients with an Optimizer ® have simultaneously a pacemaker - or ICD implant. A special extra monitor will note if there are probable interferences with these pacemaker- or ICD implants.	6 months	No