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NCT01999712 · ClinicalTrials.gov registry record
Right Ventricular Failure After Implantation of Left Ventricular Assist Devices
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 83
- Enrollment target
NCT01999712: Completed study, sponsored by Emory University.
NCT01999712 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999712 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 83 participants
- Enrollment target
Study Summary
The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery. Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are: 1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery? 2. Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF? To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography. Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and consid
Primary Outcome
Right ventricular failure (RVF) at 90 days, defined as RVF-related death (multi-organ failure), need for inhaled nitric oxide postoperatively for ≥48h, need for post-operative inotropes for ≥14 days, reinstitution of inotropes beyond 14 days, or need for a RV assist device (RVAD)
Interventions
- PROCEDURE Echocardiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-12-31 |
What the finished NCT01999712 record still lists
NCT01999712 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 83 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Echocardiography is the first listed.
NCT01999712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999712 about?
NCT01999712 is a clinical study titled "Right Ventricular Failure After Implantation of Left Ventricular Assist Devices". The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must w...
What is the current status of trial NCT01999712?
This trial is currently completed. The enrollment target is 83 participants. The study started on 2013-07. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT01999712?
The interventions under investigation include: Echocardiography (PROCEDURE).
Who is sponsoring clinical trial NCT01999712?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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