A clinical study to evaluate the benefits of frequent AV/PV and V-V delay optimization using QuickOptTM in patients with CRT-D devices.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Heart Failure
- Registration Number
- CTRI/2009/091/000775
- Lead Sponsor
- SJM International Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
1.CRT-D indications and be implanted with an SJM CRT-D device with VV timing and a compatible lead system.
2.Able to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
3.Geographically stable and willing to comply with follow-up.
4.Adequate echocardiographic images to measure LV end systolic volume.
Exclusion Criteria
1.Epicardial ventricular lead system.
2.Ability to walk ≥ 450 meters in 6 minutes
3.Limited intrinsic atrial activity (≤ 40 bpm).
4.Persistent or permanent AF.
5.2° or 3° heart block.
6.Life expectancy is less than 1 year.
7.Patient is pregnant.
8.Receiving IV inotropic agents.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical benefit (reduction in SAS of at least 1 class or a 25% or larger improvement in 6 minute hall walk distance) plus structural remodeling (15% or greater reduction in left LV end systolic volume or ≥ 5% absolute improvement in echo-derived LV EF)Timepoint: Time Frame: 12 months
- Secondary Outcome Measures
Name Time Method 1)Rate of late (12-month) versus early (3 month) response to CRT Rate of late (12-month) versus early (3 month) response to CRT<br>2)Changes in BNP<br>3)Inter-/intra-ventricular dysynchronyTimepoint: Time Frame: 3 and 12 months<br>