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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 - HEMOCART

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55084
Enrollment
10
Registered
2021-01-22
Start date
2021-02-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic Heart Failure

Interventions

CRT candidates will receive device optimization and simultaneous study measurements directly after device implantation. Patients will undergo invasive pressure-volume (PV) loop assessment during var

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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
Volume-time curves obtained during various pacing configurations will be compared between the non-invasive method (HCP) and the invasive method (conductance catheter).

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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026