Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment
NCT ID: NCT01426321
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-08-31
2018-12-31
Brief Summary
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New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Imaging guided LV lead positioning
Imaging guided LV lead positioning
LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images.
Standard LV lead positioning
The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available.
No interventions assigned to this group
Interventions
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Imaging guided LV lead positioning
LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images.
Eligibility Criteria
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Inclusion Criteria
* Wide QRS ≥ 120 milliseconds on standard ECG.
* LV systolic dysfunction (EF ≤ 35%).
* Written informed consent.
* Accepted for CRT-P or CRT-D treatment
Exclusion Criteria
* Recent myocardial infarction (\< 3 months).
* Significant valve disease
* Chronic atrial fibrillation
* Pregnancy
* Severely impaired renal function (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
* Unable to give written informed consent.
18 Years
ALL
No
Sponsors
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Crafoord Foundation
OTHER
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Rasmus Borgquist, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skane
Locations
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Skane University Hospital
Lund, , Sweden
Countries
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References
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Borgquist R, Carlsson M, Markstad H, Werther-Evaldsson A, Ostenfeld E, Roijer A, Bakos Z. Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study. JACC Clin Electrophysiol. 2020 Oct;6(10):1300-1309. doi: 10.1016/j.jacep.2020.05.011. Epub 2020 Aug 12.
Other Identifiers
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CRTCLIN01
Identifier Type: -
Identifier Source: org_study_id
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