An interventional study of Guide CRT Software Prototype in Cardiovascular Diseases, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment
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).
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's planned enrollment of 218 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Device: Guide CRT Software Prototype
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
>15% reduction in end systolic volume
\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
Time frame: 6 months
5% absolute increase in left ventricular ejection fraction
5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram
Time frame: 6 months
>10% reduction in end diastolic volume
\>10% reduction in end diastolic volume as derived from 2D echocardiogram
Time frame: 6 months
Plan to share: No
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Guy's and St Thomas' NHS Foundation Trust