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Hemodynamic Cardiac Profiler for Assessment of Acute Hemodynamic Changes in Heart Failure Patients Undergoing Cardiac Resynchronization Therapy

Completed
Conditions
Chronic Heart Failure
10019280
Registration Number
NL-OMON55084
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

Patients need to fulfil the 2013 guideline of the European Society of
Cardiology criteria for cardiac pacing and cardiac resynchronisation therapy
upon receiving a CRT.

Exclusion Criteria

Age <18
Frequent extrasystole (more than 10%)
Artificial aortic valve or aortic stenosis
LV volume > 300 ml
Other implantable devices than CRT/PM/ICD in the upper body
Structural anatomical / congenital cardiac *deviations*

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Volume-time curves obtained during various pacing configurations will be<br /><br>compared between the non-invasive method (HCP) and the invasive method<br /><br>(conductance catheter). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. Evaluate derivatives of volume-time curves (i.e. stroke volume, max volume,<br /><br>min volume, 1/3 FFR) and compare these derivatives between different pacing<br /><br>settings and between the HCP volume-time curve and conductance catheter<br /><br>volume-time curve.<br /><br>2. Assessment of pressure data during different pacing settings and comparison<br /><br>between the invasive pressure measurements (conductance catheter) and the<br /><br>non-invasive pressure measurements (Nexfin)<br /><br>3. Reconstruction of pressure-volume (PV) loops with Nexfin and HCP data and<br /><br>compare these PV- loops with PV-loops obtained using the conductance catheter.</p><br>
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