N/A
Completed N=2,005
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Source: ClinicalTrials.gov NCT03075215 ↗Enrolled (actual)
2,005
Serious AEs
28.5%
Results posted
Oct 2023
Primary outcomePrimary: CRT Response Rate — 918; 312; 328 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CRT Response Rate |
918; 312; 328 | — |
| PRIMARY Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications |
97.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03075215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.