Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Purpose
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.
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies. - Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure. - Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws - Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol
Exclusion Criteria
- Subject with documented life expectancy of less than 12 months - Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device). - Subject who have had a pre-existing CRT device - Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager - Women of childbearing potential who are or might be pregnant at time of study enrolment - Any contra-indication to receive a CRT-D device per local guidelines
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
More Details
- NCT ID
- NCT03075215
- Status
- Completed
- Sponsor
- Boston Scientific Corporation