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NCT01832610 · ClinicalTrials.gov registry record
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
A clinical trial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- 101
- Enrollment target
NCT01832610: Completed study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01832610 is a clinical trial that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 101 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832610 has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
Study Summary
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
Primary Outcome
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
Interventions
- DEVICE HeartWare® VAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-03 |
What the finished NCT01832610 record still lists
NCT01832610 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which HeartWare® VAS is the first listed.
NCT01832610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832610 about?
NCT01832610 is a clinical study titled "Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials". Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
What is the current status of trial NCT01832610?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2013-01. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01832610?
The interventions under investigation include: HeartWare® VAS (DEVICE).
Who is sponsoring clinical trial NCT01832610?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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