Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy (Impel)

University of Oslo (UIO)

Status: Unknown

Conditions: Heart Failure, Systolic

Treatments: Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03640000

2014/1223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Determination of impedance signals

Experimental group

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.

Treatment:

Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy