Hemodynamic Cardiac Profiler for Assessment of Acute Hemodynamic Changes in Heart Failure Patients Undergoing Cardiac Resynchronization Therapy
Recruiting
- Conditions
- Heart failure
- Registration Number
- NL-OMON20610
- Lead Sponsor
- VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess clinical feasibility and accuracy of HCP measurements in CRT patients during different pacing settings. We will evaluate the accuracy of LV volumetric measurements by comparing volume-time curves obtained using HCP with the conductance catheter (gold standard) measurements.
- Secondary Outcome Measures
Name Time Method 1.Evaluate derivatives of volume-time curves (i.e. stroke volume, max volume, min volume, 1/3 FFR) and compare these derivatives between different pacing settings and between the HCP volume-time curve and conductance catheter volume-time curve.<br>2.Assessment of pressure data during different pacing settings and comparison between the invasive pressure measurements (conductance catheter) and the non-invasive pressure measurements (Nexfin).<br>3.Reconstruction of pressure-volume (PV) loops with Nexfin and HCP data and compare these PV- loops with PV-loops obtained using the conductance catheter.