Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy
Not Applicable
- Conditions
- Heart Failure
- Registration Number
- JPRN-UMIN000002304
- Lead Sponsor
- St. Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Not provided
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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