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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
| Cardiff Metropolitan University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Medical Therapy | Sham Comparator | Routine Medical Therapy |
|
| Routine Medical Therapy + LVP | Experimental | Routine Medical Therapy + LVP |
|
| Routine Medical Therapy + BiVP | Experimental | Routine Medical Therapy + BiVP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-pacemaker device set to Routine Medical Therapy | Device | Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LV area between rest and exercise across the three pacing states | 12 weeks | |
| Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaheer Yousef | Cardiff and Vale University Health Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wales | Cardiff | CF14 4UJ | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CRT-pacemaker device set to Routine Medical Therapy + LVP | Device | Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP |
|
| CRT-pacemaker device set to Routine Medical Therapy + BiVP | Device | Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP |
|
| Change in rest and exercise E/E' on echocardiography across the three pacing states | 12 weeks |