Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy

Heart Failure, Systolic Clinical Trial

— Impel  

Official title:

Acute Changes in Bioimpedance During Cardia Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640000
• Other study ID #: 2014/1223
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: August 2018
• Source: Oslo University Hospital
• Contact: Hans Henrik Odland, MD, PhD
• Phone: 23070000
• Email: h.h.odland[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Diagnostic Test:
• Impedance measurements in Cardiac Resynchronization therapy
Bioimpedance measurements

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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