Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
Public ClinicalTrials.gov record NCT02202434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02202434
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,425 participants
Conditions and interventions
Conditions
Interventions
- Lotus Valve System Device
- CoreValve/Evolut R Transcatheter Aortic Valve Replacement System Device
- LOTUS Edge Valve System Device
Device
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 22, 2014 (Actual)
- Primary completion
- Mar 8, 2017 (Actual)
- Completion
- May 21, 2021 (Actual)
- Last update posted
- Dec 17, 2021
2014 – 2021
United States locations
- U.S. sites
- 49
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Good Samaritan | Phoenix | Arizona | 85018 | — |
| Scottsdale Healthcare - Shea | Scottsdale | Arizona | 85258 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Veteran's Administration Palo Alto Medical Center | Palo Alto | California | 94304 | — |
| University of California at Davis Medical Center | Sacramento | California | 95817 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant Mease Healthcare System | Clearwater | Florida | 33756 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | — |
| Emory University Hospital | Atlanta | Georgia | 30308 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Evanston Hospital | Evanston | Illinois | 60201 | — |
| St. John's Hospital - Prairie Cardiovascular Consultants | Springfield | Illinois | 62701 | — |
| St. Vincent's Hospital | Indianapolis | Indiana | 46290 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital | Petoskey | Michigan | 49770 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Abbott Northwestern Hospital - Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine - Barnes Jewish Medical Center | St Louis | Missouri | 63110 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07960 | — |
| Kaleida Health | Buffalo | New York | 14203 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Columbia University Medical Center | New York | New York | 10021 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| NC Heart and Vascular Research - Rex Hospital | Raleigh | North Carolina | 27607 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Ohio Health Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| Methodist DeBakey Heart & Vascular Center | Houston | Texas | 77030 | — |
| Methodist Heart Hospital | San Antonio | Texas | 78229 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| University of Washington Medical Center | Seattle | Washington | 98105 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02202434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 17, 2021 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02202434 live on ClinicalTrials.gov.