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NCT04458103 · ClinicalTrials.gov registry record · NA
Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 161
- Enrollment target
NCT04458103: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT04458103 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 161 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04458103, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 161 participants
- Enrollment target
Study Summary
Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative or intraoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF. This trial will include both a prospective interventional cohort and a retrospective control cohort. The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will preemptively receive an RVAD (either the ProtekDuo or Impella RP) surrounding LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus percutaneous RVAD placement perioperatively to LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care. Subjects who consent to the study will undergo peri-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control co
Interventions
- DEVICE Percutaneous RVAD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2023-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458103
The ClinicalTrials.gov registry entry for NCT04458103 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Percutaneous RVAD is the first listed.
NCT04458103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04458103 about?
NCT04458103 is a clinical study titled "Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD". Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length o...
What is the current status of trial NCT04458103?
This trial is currently terminated. It is a NA study. The enrollment target is 161 participants. The study started on 2020-05-12. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04458103?
The interventions under investigation include: Percutaneous RVAD (DEVICE).
Who is sponsoring clinical trial NCT04458103?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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