Heart failure
Conditions
Interventions
Patient will receive a cardiovascular MRI scan and invasive pressure-vollume measurements using a conductance catheter 6 weeks after their CRT-D implantation
Sponsors
Biotronik Nederland b.v.
Eligibility
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 for this study are: - Age <18 or incapacitated adult - Significant rhythm abnormalities (atrial fibrillation or frequent extrasystole) - Artificial heart valves - Pacemaker dependency - Lactation - Documented allergic reaction to gadolinium - Subjects with severely impaired renal function ( GFR < 30 ml/min/1.73m2) - Impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this pilot study is to assess the feasibility of CMR imaging in patients implanted with a CMR compatible CRT-D. This includes assessment of both image quality and the accuracy of LV volumetric and functional measurements with and without biventricular stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Comparison of additional quantitative CMR parameters post- versus pre-implantation. - Comparison of quantitative CMR parameters during conventional CRT on versus CRT off. - Relation between baseline dyssynchrony, dyscoordination and (wasted) myocardial work, their changes in response to CRT and acute pump function improvement. | — |
Contacts
Public ContactLuuk Hopman
VUmc
Outcome results
None listed