Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02468778 · ClinicalTrials.gov registry record · NA
SHIELD II Clinical Investigation
A NA study, sponsored by Abbott Medical Devices.
- Terminated
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT02468778: Clinical Trial NA study, sponsored by Abbott Medical Devices.
NCT02468778 is a NA study that was terminated before completion, run by Abbott Medical Devices. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02468778, a NA study, was terminated before completion, sponsored by Abbott Medical Devices.
- TERMINATED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
Primary Outcome
The primary endpoint, including the following components representing important safety and effectiveness endpoints will be evaluated using the difference in event rates in the ITT population. * Cardiovascular Death * Myocardial infarction (MI) * Stroke * Any unplanned repeat revascularization (PCI or CABG) * Bleeding (BARC 3 or 5) up to 14 days post-device removal * Severe hypotension, defined as: systolic blood pressure (SBP) or augmented diastolic pressure (whichever is greater) \<90 mmHg whi
Interventions
- DEVICE HeartMate PHP
- DEVICE Any Abiomed Impella® device approved for use in high-risk PCI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-08 |
| Est. Completion | 2021-05-17 |
| Phase | NA |
Why NCT02468778 stopped before completion
NCT02468778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which HeartMate PHP is the first listed.
NCT02468778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02468778 about?
NCT02468778 is a clinical study titled "SHIELD II Clinical Investigation". The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac s...
What is the current status of trial NCT02468778?
This trial is currently terminated. It is a NA study. The enrollment target is 54 participants. The study started on 2015-08. Estimated completion is 2021-05-17.
What interventions are being tested in trial NCT02468778?
The interventions under investigation include: HeartMate PHP (DEVICE), Any Abiomed Impella® device approved for use in high-risk PCI (DEVICE).
Who is sponsoring clinical trial NCT02468778?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02468778's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia