Health Condition 1: null- Heart Failure
Conditions
Interventions
Intervention1: Patient Implanted with CRT-D Device and AV/PV and V-V delays optimized using Quick-Opt.: Patient Implanted with CRT-D Device programmed to sequential BiV pacing mode with AV/PV and V-V
Sponsors
SJM International Inc
St. Jude Medical (HK) Ltd.
Suite 1608, 16/F Exchange Tower
33 Wang Chiu Road
Kowloon Bay, Kowloon
Hong Kong SAR
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2)Changes in BNP 3)Inter-/intra-ventricular dysynchronyTimepoint: Time Frame: 3 and 12 months | — |
Countries
India
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd.
Outcome results
None listed