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NCT02202434 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
A NA study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 1,425
- Enrollment target
NCT02202434 is a NA study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 1,425 participants.
The verdict
NCT02202434, a NA study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 1,425 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
Interventions
- DEVICE Lotus Valve System
- DEVICE CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
- DEVICE LOTUS Edge Valve System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,425 participants |
| Start Date | 2014-09-22 |
| Est. Completion | 2021-05-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02202434
The ClinicalTrials.gov registry entry for NCT02202434 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1,425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lotus Valve System is the first listed.
NCT02202434 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02202434 about?
NCT02202434 is a clinical study titled "Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement". The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgic...
What is the current status of trial NCT02202434?
This trial is currently terminated. It is a NA study. The enrollment target is 1,425 participants. The study started on 2014-09-22. Estimated completion is 2021-05-21.
What interventions are being tested in trial NCT02202434?
The interventions under investigation include: Lotus Valve System (DEVICE), CoreValve/Evolut R Transcatheter Aortic Valve Replacement System (DEVICE), LOTUS Edge Valve System (DEVICE).
Who is sponsoring clinical trial NCT02202434?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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