Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy (Impel)

Acute Changes in Bioimpedance During Cardia Resynchronization Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure, Systolic
• Intervention / Treatment: Diagnostic test: Impedance measurements in Cardiac Resynchronization therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Henrik Odland, MD, PhD; Phone Number: +47 23070000; Email: h.h.odland@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Recruiting
    • Oslo University Hospital
    • Contact: Hans Henrik Odland; Email: hodland@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Determination of impedance signals; 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.	Diagnostic test: Impedance measurements in Cardiac Resynchronization therapy; Bioimpedance measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Hans Henrik Odland, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 30, 2016
• First Submitted That Met QC Criteria: August 19, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: 2014/1223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO