Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234611
Status:
UNKNOWN
Last Update Posted:
2006-11-06
First Post:
2005-10-05
Brief Title:
Localization of CRT According to Echocardiography LOCATE-Pilot Study
Sponsor:
Michigan Heart PC
Organization:
Michigan Heart PC
Study Overview
Official Title:
Localization of CRT According to Echocardiography LOCATE-Pilot Study
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Currently the majority of heart failure patients who qualify for and receive a cardiac resynchronization therapy CRT device feel better than before their implant However there are some patients who do not improve after the implant Michigan Heart is sponsoring a research study called LOCATE-Pilot to help understand whether the information from an echocardiogram performed before implanting the CRT device improves patients responses to CRT This is being done by evaluating your hearts function with an echocardiogram to measure your hearts response during therapy The study hypothesis is that response to CRT may be optimized by guiding left ventricular lead placement to the maximally delayed viable basal segment of the left ventricle
Detailed Description:
CRT is a promising treatment modality for medically-refractory New York Heart Association NYHA class III or IV heart failure HF patients with intraventricular conduction delay QRS 130 ms The randomized trials also suggest that a substantial minority of patients do not benefit either echocardiographically or clinically from CRT In the MIRACLE trial for instance 35 of patients did not clinically improve after CRT Objective reverse remodeling typically defined as 15 reduction in the end-systolic volume occurs in approximately 60 of patients Most echocardiographic studies to date have reported only short- and intermediate-term results
The objectives of the LOCATE-Pilot study are as follows 1 to determine the proportion of patients undergoing CRT or CRT with defibrillator CRT-D with interpretable pulsed-wave tissue Doppler echocardiographic signals to quantitate and localize mechanical dyssynchrony 2 to determine how frequently the LV lead can be successfully implanted in the most delayed basal segment area of maximal delay 3 to determine whether TDI guidance of CRT improves the proportion of patients with an echocardiographic response to treatment reverse remodeling at 6 months 4 to determine whether TDI guidance of CRT improves the proportion of patients with a clinical response to treatment 6 min walk time major clinical vascular events or Minnesota Living with Heart Failure Quality of Life score 5 to confirm that echocardiographic targeting of LV lead implantation is safe and does not hamper efficiency in the electrophysiological laboratory 6 to validate the peak velocity delay PVD as a predictor of CRT response using pulsed-wave Doppler tissue imaging
The LOCATE-pilot is a randomized prospective study of 60 patients undergoing implantation of a Medtronic market approved CRT system All patients will undergo a comprehensive baseline echocardiographic study in which a 6-segment model will be used to quantify dyssynchrony by the pulsed-wave Doppler technique Myocardial viability will be assessed by conventional 2D criteria and nuclear perfusion data when available Patients will be randomized to 1 of 2 groups with 30 patients per group on an intention-to-treat basis 1 Control group the implanting physician will have no knowledge of the baseline dyssynchrony assessment and use the current standard of care in the LV lead implantation and 2 Echo-Guided group the implanting physician will have full knowledge of baseline echocardiographic study and will use the dyssynchrony and viability data to guide final LV lead placement
For this pilot study patients will be followed for 6 months with a repeat Echocardiogram at 6 months The primary endpoint of the study is indexed end systolic volume decrease 15 by biplane Simpsons technique
The objectives of the LOCATE-Pilot study are as follows 1 to determine the proportion of patients undergoing CRT or CRT with defibrillator CRT-D with interpretable pulsed-wave tissue Doppler echocardiographic signals to quantitate and localize mechanical dyssynchrony 2 to determine how frequently the LV lead can be successfully implanted in the most delayed basal segment area of maximal delay 3 to determine whether TDI guidance of CRT improves the proportion of patients with an echocardiographic response to treatment reverse remodeling at 6 months 4 to determine whether TDI guidance of CRT improves the proportion of patients with a clinical response to treatment 6 min walk time major clinical vascular events or Minnesota Living with Heart Failure Quality of Life score 5 to confirm that echocardiographic targeting of LV lead implantation is safe and does not hamper efficiency in the electrophysiological laboratory 6 to validate the peak velocity delay PVD as a predictor of CRT response using pulsed-wave Doppler tissue imaging
The LOCATE-pilot is a randomized prospective study of 60 patients undergoing implantation of a Medtronic market approved CRT system All patients will undergo a comprehensive baseline echocardiographic study in which a 6-segment model will be used to quantify dyssynchrony by the pulsed-wave Doppler technique Myocardial viability will be assessed by conventional 2D criteria and nuclear perfusion data when available Patients will be randomized to 1 of 2 groups with 30 patients per group on an intention-to-treat basis 1 Control group the implanting physician will have no knowledge of the baseline dyssynchrony assessment and use the current standard of care in the LV lead implantation and 2 Echo-Guided group the implanting physician will have full knowledge of baseline echocardiographic study and will use the dyssynchrony and viability data to guide final LV lead placement
For this pilot study patients will be followed for 6 months with a repeat Echocardiogram at 6 months The primary endpoint of the study is indexed end systolic volume decrease 15 by biplane Simpsons technique
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