University Hospital Wales
Cardiff, CF14 4UJ, United Kingdom
NCT Number: NCT03215849
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
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Cardiff, CF14 4UJ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Cardiff and Vale University Health Board
Other Gov
The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
Acronym: MAPPLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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