A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes. The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography. All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order: Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
University Hospital Wales
Cardiff, United Kingdom
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
Time frame: 12 weeks
Change in LV area between rest and exercise across the three pacing states
Time frame: 12 weeks
Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states
Time frame: 12 weeks
Change in rest and exercise E/E' on echocardiography across the three pacing states
Time frame: 12 weeks
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