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.
ID
Bron
Verkorte titel
Aandoening
Heart failure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
10 CRT-D patients will receive a MRI scan and invasive pressure-volume-loop measurements 6 weeks after their CRT-D implantation
Doel van het onderzoek
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.
Onderzoeksopzet
1
Onderzoeksproduct en/of interventie
Patient will receive a cardiovascular MRI scan and invasive pressure-vollume measurements using a conductance catheter 6 weeks after their CRT-D implantation
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. 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7843 |
| Ander register | METC VUMC : 2016.032 |