Back to resultsAcute Changes in Bioimpedance During Cardiac Resynchronization Therapy (Impel)
Primary Purpose
Heart Failure, Systolic
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Impedance measurements in Cardiac Resynchronization therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure, Systolic
Eligibility Criteria
- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Determination of impedance signals
Arm Description
This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements.
Outcomes
Primary Outcome Measures
Optimization of Bioimpedance measurements
Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved.
Secondary Outcome Measures
Full Information
NCT ID
NCT03640000
First Posted
October 30, 2016
Last Updated
August 19, 2018
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03640000
Brief Title
Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy
Acronym
Impel
Official Title
Acute Changes in Bioimpedance During Cardia Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.
Detailed Description
Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Determination of impedance signals
Arm Type
Experimental
Arm Description
This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements.
Intervention Type
Diagnostic Test
Intervention Name(s)
Impedance measurements in Cardiac Resynchronization therapy
Intervention Description
Bioimpedance measurements
Primary Outcome Measure Information:
Title
Optimization of Bioimpedance measurements
Description
Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Henrik Odland, MD, PhD
Phone
23070000
Ext
+47
Email
h.h.odland@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Henrik Odland, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Henrik Odland
Email
hodland@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy
We'll reach out to this number within 24 hrs