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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: Clinical Trial NA study, sponsored by Boston Scientific Corporation.
NCT02202434 is a NA study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 1,425 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
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 |
Why NCT02202434 stopped before completion
NCT02202434 is an interventional study that assigns participants to a tested intervention. Its 1,425 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Lotus Valve System is the first listed.
NCT02202434 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02202434's enrollment target sits among peer trials
1,425 70th of 2000 higher than 1,931 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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