Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061241
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2014-02-07
Brief Title:
A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL-CRT
Brief Summary:
Cardiac resynchronisation therapy CRT using biventricular pacing BiVP is established as an effective treatment for heart failure Unfortunately up to 45 of patients do not respond with no improvement in symptoms or cardiac size Reducing the proportion of non-responders has become the key research focus in CRT
Targeting the position of the left ventricular LV pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT Several techniques have been tried for targeting lead position of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response AHR to BiVP occurs Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients or that if the information is shown to be equivalent more streamlined techniques can be designed
This study will also be able to contribute towards several important secondary questions In particular the investigators will study the possibility of using non-invasive cardiac output monitoring NICOM to assess haemodynamic response rather than an intravascular pressure monitor wire The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing
Targeting the position of the left ventricular LV pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT Several techniques have been tried for targeting lead position of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response AHR to BiVP occurs Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients or that if the information is shown to be equivalent more streamlined techniques can be designed
This study will also be able to contribute towards several important secondary questions In particular the investigators will study the possibility of using non-invasive cardiac output monitoring NICOM to assess haemodynamic response rather than an intravascular pressure monitor wire The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14SC0148 | OTHER | UK NRES | None |