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NCT03618095 · ClinicalTrials.gov registry record · NA
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
A NA study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 382
- Enrollment target
NCT03618095: Clinical Trial NA study, sponsored by Boston Scientific Corporation.
NCT03618095 is a NA study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 382 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03618095, a NA study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 382 participants
- Enrollment target
Study Summary
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
Primary Outcome
Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)
Interventions
- DEVICE LOTUS Edge Valve System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
Why NCT03618095 stopped before completion
NCT03618095 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which LOTUS Edge Valve System is the first listed.
NCT03618095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03618095 about?
NCT03618095 is a clinical study titled "REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects". REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
What is the current status of trial NCT03618095?
This trial is currently terminated. It is a NA study. The enrollment target is 382 participants. The study started on 2019-01-14. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT03618095?
The interventions under investigation include: LOTUS Edge Valve System (DEVICE).
Who is sponsoring clinical trial NCT03618095?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03618095's enrollment target sits among peer trials
382 273rd of 2000 higher than 1,728 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
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