Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy

Not Applicable

• Conditions: Heart Failure, Systolic
• Interventions: Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy

• Registration Number: NCT03640000
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-10-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Determination of impedance signals	Impedance measurements in Cardiac Resynchronization therapy	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.

Primary Outcome Measures

Name	Time	Method
Optimization of Bioimpedance measurements	3 years	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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway