The objective of this study is to assess the feasibility of HCP measurements in CRT patients during different pacing settings. We will evaluate the accuracy of LV volumetric measurements in patients with an implanted CRT. For this evaluation, LV…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Volume-time curves obtained during various pacing configurations will be
compared between the non-invasive method (HCP) and the invasive method
(conductance catheter).
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 and
unfortunately robust non-invasive alternatives are currently lacking. The
Hemodynamic Cardiac Profiler (HCP) can measure left ventricular (LV) stroke
volume 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 (Nexfin) might be promising for CRT device
optimization.
Study objective
The objective of this study is to assess the feasibility of HCP measurements in
CRT patients during different pacing settings. We will evaluate the accuracy of
LV volumetric measurements in patients with an implanted CRT. For this
evaluation, LV volumes and the effects of biventricular pacing on LV function
will be related to *the gold standard* invasively assessed changes in LV pump
function with the conductance catheter.
Study design
Prospective observational study with invasive measurements, implemented after
CRT implantation.
Intervention
CRT candidates will receive device optimization and simultaneous study
measurements directly after device implantation. Patients will undergo invasive
pressure-volume (PV) loop assessment during various biventricular pacing
settings to obtain functional and volumetric measurements. In addition, the
optimal stimulation configuration will be programmed in the device which
benefits the patient. Simultaneously, measurements with the HCP (volumes) and
Nexfin (pressures) will be performed to assess feasibility and compare the
non-invasively achieved data with the invasively achieved data.
Study burden and risks
The introduction of non-invasive CRT optimization techniques to study the
effects of CRT might result in better understanding of underlying mechanisms.
Ultimately this might improve CRT benefit. Participation in this study requires
an additional invasive procedure. This procedure will be scheduled directly
after device implantation. The patients will have direct benefit from the
invasive procedure, since patient specific optimal device settings will be
assessed and programmed in the device.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
Medical products/devices used
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 |
|---|---|
| CCMO | NL72894.029.20 |