Hemodynamic Cardiac Profiler for Assessment of Acute Hemodynamic Changes in Heart Failure Patients Undergoing Cardiac Resynchronization Therapy
- Conditions
- Chronic Heart Failure10019280
- 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
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.
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
Name Time Method <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
Name Time Method <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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