No registrations found.
ID
Source
Brief title
Health condition
Heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Cardiac resynchronization therapy (CRT) is an effective therapy for heart failure patients with electromechanical ventricular dyssynchrony. Device optimization can be achieved by invasive pressure-volume measurements. Unfortunately, robust non-invasive alternatives are currently lacking. The Hemodynamic Cardiac Profiler (HCP) can measure left ventricular (LV) stroke volume non-invasively using ventricular field recognition by applying six electrode pairs over the frontal thoracic skin. Combining this novel non-invasive method with non-invasive pressure measurements might allow non-invasive CRT device optimization.
Study objective
We hypothesise that HCP provides reproducible and accurate measurements of LV volume changes during different CRT pacing settings which are comparable with invasive conductance catheter measurements.
Study design
1 (invasive and non-invasive measurements on the cath-lab using the conductance catheter, HCP and Nexfin)
Intervention
Invasive and non-invasive volume measurements
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”
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9375 |
| Other | METC VUmc : 2020.441 |