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| Name | Class |
|---|---|
| King's College London | OTHER |
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The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.
The primary endpoint will be assessed by calculating the difference in the proportion of responders (>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard CRT implantation | No Intervention | ||
| MRI guided CRT implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guide CRT Software Prototype | Device | The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation |
| Measure | Description | Time Frame |
|---|---|---|
| >15% reduction in end systolic volume | >15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 5% absolute increase in left ventricular ejection fraction | 5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram | 6 months |
| >10% reduction in end diastolic volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
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|
>10% reduction in end diastolic volume as derived from 2D echocardiogram
| 6 months |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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