Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399594
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2006-11-13
Brief Title:
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Investigating Non-response to Cardiac Resynchronization Evaluation of Methods to Eliminate Non-response Target Appropriate Lead Location INCREMENTAL
Status:
COMPLETED
Status Verified Date:
2015-11
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:
INCREMENTAL
Brief Summary:
Identifying optimizing strategies to reduce the burden of heart failure is vital Despite advances in pharmacotherapy patients with heart failure are at high risk for death hospitalization Cardiac resynchronization therapy CRT synchronizes ventricular mechanical activity improves cardiac output reduces HF symptoms However 50 of patients do not clearly respond to CRT Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response
This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs usual lateral wall lead placement
This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs usual lateral wall lead placement
Detailed Description:
Background Identifying optimizing strategies to reduce the burden of heart failure HF is vital Despite advances in pharmacotherapy patients with HF are at high risk for death hospitalization Over 25 of patients with systolic HF have dyssynchronous ventricular contraction that results in paradoxical septal motion further impairing left ventricular LV function HF progression Cardiac resynchronization therapy CRT synchronizes ventricular mechanical activity improves cardiac output reduces HF symptoms However 50 of patients do not clearly respond to CRT Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response
Screening Mechanical synchrony is vitally important in optimizing CRT response Patients will be pre-screened with echocardiograms echo CRT provided to only those with dyssynchrony The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65
CRT response The combined use of a valid simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders These outcomes will be assessed using the Specific Activity Scale radionuclide angiography RNA respectively
Primary hypothesis Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs usual lateral wall lead placement CRT response will be defined as 10 relative reduction in LV end systolic volume 1 Specific Activity Scale class improvement
Screening Mechanical synchrony is vitally important in optimizing CRT response Patients will be pre-screened with echocardiograms echo CRT provided to only those with dyssynchrony The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65
CRT response The combined use of a valid simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders These outcomes will be assessed using the Specific Activity Scale radionuclide angiography RNA respectively
Primary hypothesis Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs usual lateral wall lead placement CRT response will be defined as 10 relative reduction in LV end systolic volume 1 Specific Activity Scale class improvement
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