Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy

UMIN ID: UMIN000002304

Registered date:06/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 2009/06/01
• Target sample size: 450
• Countries of recruitment: Japan,Asia(except Japan),North America,Australia,Europe
• Study type: Interventional

Intervention(s)

The paced / sensed AV and V-V delays will be optimized using QuickOpt. Optimization will be performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.
The paced / sensed AV and V-V delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. Patients can be optimized only once within the first 4 weeks post implant.

Outcome(s)

• Primary Outcome: A combination of symptomatic improvement (>=1 class reduction in specific activity scale (SAS) or >= 25% improvement in 6 minute walk test distance) and LV remodeling (>= 15% reduction LV end systolic volume or >= 5% improvement in LVEF)
• Secondary Outcome: 1) Rate of late (12-month) response to CRT 2) Changes in B-type natriuretic peptide (BNP) in correlation to cardiac remodeling 3) Inter- / intra-ventricular dyssynchrony compared to usual optimization

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patient has an epicardial ventricular lead system. 2) Patient has the ability to walk >= 450 meters in 6 minutes. 3) Patient has limited intrinsic atrial activity (<= 40 bpm). 4) Patient has persistent or permanent AF. 5) Patient has a second or third degree heart block. 6) Patient's life expectancy is less than 1 year 7) Patient is less than 18 years old. 8) Patient is pregnant. 9) Patient is on IV inotropic agents.

Related Information

• Primary Sponsor: St. Jude Medical
• Secondary Sponsor: University of Calgary (Derek Exner, MD)
• Source(s) of Monetary Support: St. Jude Medical Japan Co., Ltd.
• Secondary ID(s): NCT00489177