A Phase 2/3 interventional study of Advanced Imaging Guided LV lead placement and Standard LV lead placement in Heart Failure, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-07.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Phase 2/3, Interventional, and Treatment
Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 270 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Standard LV lead placement
Other: Advanced Imaging Guided LV lead placement
Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.
Standard LV lead placement not guided by advanced imaging
Change in the proportion of CRT responders
Time frame: 6 months
Change in echo derived end systolic (ESV) and diastolic volumes
Time frame: 6 months
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)
Time frame: 6 months
Procedural success
Time frame: 0 months
Procedure duration
Time frame: 0 months
Radiation dose
Time frame: 0 months
Contrast dose
Time frame: 0 months
Procedural complications
Time frame: 6 months
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust