Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489177
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2007-06-20
Brief Title:
Optimal Programming to Improve Mechanical Indices Symptoms and Exercise in Cardiac Resynchronization Therapy
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Optimal Programming to Improve Mechanical Indices Symptoms and Exercise in Cardiac Resynchronization Therapy
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:
OPTIMISE-CRT
Brief Summary:
This international study is assessing if repeat adjustment of the timing between the three leads in a cardiac resynchronization therapy CRT defibrillator will increase the likelihood of benefit symptoms and heart function compared to usual device programming The hypothesis is that QuickOpt facilitated serial optimization of sensed atrioventricular sAV paced atrioventricular pAV and inter-ventricular VV timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care
Detailed Description:
Cardiac resynchronization therapy CRT is primarily designed to synchronize the mechanical activity of the heart While CRT is beneficial in average a sizable proportion of patients do not clearly benefit from respond to CRT Whether routinely optimizing the timing between the atria and ventricles AV timing and the timing between the left and right ventricles VV timing will significantly increase the likelihood of patients benefiting from responding to CRT is unknown
The combination of simple and reliable measures of functional capacity specific activity score SAS and 6-minute walk distance with echocardiographic measures of left ventricular LV volume and ejection fraction EF is a practical way of defining response to CRT
Based on surveys most patients receiving CRT devices do not have formal optimization of AV and VV timing This is largely because the usefulness of this is questionable and significant resources are required to perform detailed echo measurements
A method for estimating optimal sensed AV sAV paced AV pAV and VV timing using intra-cardiac electrograms I-EGM has been developed QuickOptTM and offers a quick simple and inexpensive means to optimize both CRT timing However the utility of QuickOptTM optimization is unproven
Primary hypothesis QuickOpt facilitated serial optimization of sAV pAV and VV timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care Clinical response will be defined as a reduction in SAS of 1 class or a 25 or larger improvement in 6 minute hall walk distance at 12 months versus baseline Structural remodeling will be defined as a 15 or greater reduction in left LV end systolic volume or 5 absolute improvement in echo-derived LV EF at 12 months versus baseline
Methods Initially a sub-study of FREEDOM NCT00418314 Now an independent trial Double-blind randomized comparison of serial QuickOpt optimization of sAV pAV and VV timing QuickOpt versus usual care Usual in patients with highly symptomatic heart failure undergoing CRT implantation Stratification by etiology of LV dysfunction will be undertaken Serial optimization of sAV pAV and VV timing will be performed in the QuickOptTM group immediately post-randomization and at 3 6 and 9 months post-randomization Final outcome will be assessed at 12 months post-randomization
Statistical aspects 450 patients 225 group will provide 85 power to detect a 15 absolute improvement in the rate of response to CRT with QuickOptTM versus usual care The proportion of responders will be compared using a Mantel-Haenszel stratified analysis adjusted for lead position anterior versus non-anterior and using an intention-to-treat analysis
Overview Up to 50 sites in Canada Europe Asia and the United States will enroll patients over 36 months Countries presently enrolling patients include Canada the United States Switzerland Italy Belgium Denmark Austria France Spain the United Kingdom the Netherlands China Hong Kong and Japan
The combination of simple and reliable measures of functional capacity specific activity score SAS and 6-minute walk distance with echocardiographic measures of left ventricular LV volume and ejection fraction EF is a practical way of defining response to CRT
Based on surveys most patients receiving CRT devices do not have formal optimization of AV and VV timing This is largely because the usefulness of this is questionable and significant resources are required to perform detailed echo measurements
A method for estimating optimal sensed AV sAV paced AV pAV and VV timing using intra-cardiac electrograms I-EGM has been developed QuickOptTM and offers a quick simple and inexpensive means to optimize both CRT timing However the utility of QuickOptTM optimization is unproven
Primary hypothesis QuickOpt facilitated serial optimization of sAV pAV and VV timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care Clinical response will be defined as a reduction in SAS of 1 class or a 25 or larger improvement in 6 minute hall walk distance at 12 months versus baseline Structural remodeling will be defined as a 15 or greater reduction in left LV end systolic volume or 5 absolute improvement in echo-derived LV EF at 12 months versus baseline
Methods Initially a sub-study of FREEDOM NCT00418314 Now an independent trial Double-blind randomized comparison of serial QuickOpt optimization of sAV pAV and VV timing QuickOpt versus usual care Usual in patients with highly symptomatic heart failure undergoing CRT implantation Stratification by etiology of LV dysfunction will be undertaken Serial optimization of sAV pAV and VV timing will be performed in the QuickOptTM group immediately post-randomization and at 3 6 and 9 months post-randomization Final outcome will be assessed at 12 months post-randomization
Statistical aspects 450 patients 225 group will provide 85 power to detect a 15 absolute improvement in the rate of response to CRT with QuickOptTM versus usual care The proportion of responders will be compared using a Mantel-Haenszel stratified analysis adjusted for lead position anterior versus non-anterior and using an intention-to-treat analysis
Overview Up to 50 sites in Canada Europe Asia and the United States will enroll patients over 36 months Countries presently enrolling patients include Canada the United States Switzerland Italy Belgium Denmark Austria France Spain the United Kingdom the Netherlands China Hong Kong and Japan
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