Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00748735
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2008-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Sponsor:
RWTH Aachen University
Organization:
Study Overview
Official Title:
Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging
Status:
COMPLETED
Status Verified Date:
2008-01
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:
None
Brief Summary:
Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.
Detailed Description:
In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.
Study Oversight
Has Oversight DMC:
False
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?: