At a glance
ClinicalIndex Comparison Record- ✓Implanted or upgraded with NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead per BSC labeling
- ✓Enrollment between 1 and 21 calendar days post-implantation
- ✓Age ≥18 years or legal age per country/national law
- ✓Willing and capable of complying with follow-up visits and procedures per protocol
- ✕Documented life expectancy <12 months
- ✕Currently on active heart transplant list or has LVAD or other mechanical circulatory support device
- ✕Pre-existing CRT device
- ✕Enrolled in concurrent clinical trial without prior written BSC approval
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
In Brief
An observational study evaluating Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) for Heart Failure. Completed, enrolled 2,044 participants across 139 sites in 15 countries.
Detailed Summary
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.
Study Details
Timeline
Interventions
The optimization during the standard of care visits in the first 12 months following implantation