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NCT03232944 · ClinicalTrials.gov registry record
Personalized CRT - MPP Post Approval Study
A clinical trial, sponsored by Medtronic.
- Completed
- Registry status
- 1,338
- Enrollment target
NCT03232944: Completed study, sponsored by Medtronic.
NCT03232944 is a clinical trial that has completed, run by Medtronic. The registered enrollment target is 1,338 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03232944 has completed, sponsored by Medtronic.
- COMPLETED
- Registry status
- 1,338 participants
- Enrollment target
Study Summary
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
Primary Outcome
To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
Interventions
- DEVICE Cardiac Resynchronization Therapy - MPP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,338 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2021-01-07 |
What the finished NCT03232944 record still lists
NCT03232944 is an observational study that tracks outcomes without assigning an intervention. Its 1,338 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Cardiac Resynchronization Therapy - MPP is the first listed.
NCT03232944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03232944 about?
NCT03232944 is a clinical study titled "Personalized CRT - MPP Post Approval Study". The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes t...
What is the current status of trial NCT03232944?
This trial is currently completed. The enrollment target is 1,338 participants. The study started on 2017-07-05. Estimated completion is 2021-01-07.
What interventions are being tested in trial NCT03232944?
The interventions under investigation include: Cardiac Resynchronization Therapy - MPP (DEVICE).
Who is sponsoring clinical trial NCT03232944?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
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