Back to resultsTENS in Optimizer(R) Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Stimulette r4x
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
before-after
Arm Description
TENS stimulation neck and thigh
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02692690
First Posted
January 28, 2016
Last Updated
February 22, 2016
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02692690
Brief Title
TENS in Optimizer(R) Patients
Official Title
Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
before-after
Arm Type
Experimental
Arm Description
TENS stimulation neck and thigh
Intervention Type
Device
Intervention Name(s)
Stimulette r4x
Primary Outcome Measure Information:
Title
The patients with CCM-system are assessed for EMI during TENS-application
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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TENS in Optimizer(R) Patients
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