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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20610
Enrollment
10
Registered
2021-03-22
Start date
2021-03-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Invasive and non-invasive volume measurements

Sponsors

VUmc
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: - Age 300 ml - Other implantable devices than CRT/PM/ICD in the upper body - Structural anatomical / congenital cardiac “deviations”

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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). 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.

Contacts

Public ContactLuuk Hopman

VUmc

l.hopman@amsterdamumc.nl0204441405

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)