No registrations found.
ID
Source
Brief title
Health condition
Heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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.
Background summary
10 CRT-D patients will receive a MRI scan and invasive pressure-volume-loop measurements 6 weeks after their CRT-D implantation
Study objective
CMR imaging is feasible and accurate to measure LV volumes and function in patients implanted with a CMR compatible CRT-D, with and without biventricular stimulation.
Study design
1
Intervention
Patient will receive a cardiovascular MRI scan and invasive pressure-vollume measurements using a conductance catheter 6 weeks after their CRT-D implantation
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
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
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 | NL7843 |
| Other | METC VUMC : 2016.032 |