Ignite Creation Date:
2025-12-17 @ 10:01 PM
Ignite Modification Date:
2025-12-18 @ 2:54 AM
Study NCT ID:
NCT00764075
Status:
None
Last Update Posted:
2011-07-07 00:00:00
First Post:
2008-09-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Guided Placement of CRT-Leads
Sponsor:
None
Organization:
Study Overview
Official Title:
CT and 3D-Echocardiography Placement of CRT-Leads
Status:
None
Status Verified Date:
2011-07
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:
EK138/08
Brief Summary:
Patients will be allocated to two groups with either
1. Guided implantation of the left ventricular lead
2. Empirical implantation of the left ventricular lead (current clinical standard)
For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.
For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.
In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:
1. Technical success in placing the electrode in the target vessel.
2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
1. Guided implantation of the left ventricular lead
2. Empirical implantation of the left ventricular lead (current clinical standard)
For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.
For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.
In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:
1. Technical success in placing the electrode in the target vessel.
2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
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?: