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UMIN ID: UMIN000002304

Registered date:06/08/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHeart Failure
Date of first enrollment2009/06/01
Target sample size450
Countries of recruitmentJapan,Asia(except Japan),North America,Australia,Europe
Study typeInterventional
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.


Primary OutcomeA 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 Outcome1) 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 minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Address Column Minami Aoyama, 3Flr., 7-1-5, Minami-Aoyama, Minato-ku, Tokyo Japan Japan
Telephone 03-5766-8215
Affiliation St. Jude Medical Japan Co., Ltd Clinical Affairs
scientific contact
Name Morio Shoda
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo Japan Japan
Affiliation Tokyo Women's Medical University Hospital Cardiology