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NCT03075215 · ClinicalTrials.gov registry record
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 2,044
- Enrollment target
NCT03075215: Completed study, sponsored by Boston Scientific Corporation.
NCT03075215 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 2,044 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075215 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 2,044 participants
- Enrollment target
Study 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.
Primary Outcome
The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were cla
Interventions
- DEVICE Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,044 participants |
| Start Date | 2017-04-14 |
| Est. Completion | 2021-11-15 |
What the finished NCT03075215 record still lists
NCT03075215 is an observational study that tracks outcomes without assigning an intervention. Its 2,044 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) is the first listed.
NCT03075215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03075215 about?
NCT03075215 is a clinical study titled "Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry". 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 ...
What is the current status of trial NCT03075215?
This trial is currently completed. The enrollment target is 2,044 participants. The study started on 2017-04-14. Estimated completion is 2021-11-15.
What interventions are being tested in trial NCT03075215?
The interventions under investigation include: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) (DEVICE).
Who is sponsoring clinical trial NCT03075215?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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