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.
ID
Bron
Verkorte titel
Aandoening
Heart failure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1 (invasive and non-invasive measurements on the cath-lab using the conductance catheter, HCP and Nexfin)
Onderzoeksproduct en/of interventie
Invasive and non-invasive volume measurements
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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”
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9375 |
| Ander register | METC VUmc : 2020.441 |