chronic heart failure
Conditions
Interventions
CRT candidates will receive a full CMR examination prior to device
implantation. Six weeks after CRT-D implantation, CMR imaging will be repeated
during intrinsic rhythm and biventricular pacing. Su
Sponsors
Vrije Universiteit Medisch Centrum
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. In order to participate in this study, a subject must meet all of the following criteria: - Chronic heart failure - New York Heart Association (NYHA) functional class II, III or ambulant IV - QRS duration * 120ms - Left bundle branch block - Optimal pharmacological therapy - LV ejection fraction * 35% - Sinus rhythm
Exclusion criteria
Exclusion criteria: The exclusion criteria applying for this study are: - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is CMR cine image quality, quantified by grading 17 LV segments on a 5-point grading scale (grade 1 is excellent and 5 non-diagnostic). Image quality will be compared post- versus pre-implantation. Quantitative LV functional and volumetric CMR parameters will be determined during intrinsic rhythm and during biventricular stimulation, this will be compared to pre-implantation CMR measurements (intrinsic rhythm) and invasive measurements (biventricular stimulation). | — |
Secondary
| Measure | Time frame |
|---|---|
| To reach the secondary objectives, the following parameters will be evaluated : 1. Comparison of quantitative CMR parameters post- versus pre-implantation. These parameters are derived from cine (LV mass), tagging (regional strain, torsion, dyssynchrony, discoordination), phase contrast imaging (cardiac output, diastolic function, mitral regurgitation volume) and DCE (scar mass, scar localization) images. During the post-implantation CMR examination additional LV lead localisation will be performed. See chapter 6.2.1. for detailed CMR scan protocol. 2. Comparison of quantitative CMR parameters during CRT on versus CRT off. Functional parameters derived from cine images (LV volumes / EF, LV mass), tagged images (regional strain, torsion, dyssynchrony, discoordination) and phase contrast imaging (cardiac output, diastolic function, mitral regurgitation volume) will be compared. See chapter 6.2.1. for detailed outline. 3. Relation between baseline dyssynchrony, discoordination and (wasted) work, their changes in response to CRT and pump function improvement before and after device optimization. During the invasive study, pump function is determined by Stroke work (SW), directly calculated as the area of the pressure-volume loop. The effect of biventricular pacing is calculated as the relative SW change compared with the mean of the two flanking baseline measurements. Changes in dyssynchrony, discoordination and work parameters are related to changes in SW. See chapter 6.2.1 for details on the CMR scan protocol and chapter 6.2.3. for details on the invasive study. | — |
Countries
Netherlands
Outcome results
None listed