Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
Public ClinicalTrials.gov record NCT02768402. 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
Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
Study identification
- NCT ID
- NCT02768402
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- May 31, 2016
- Primary completion
- Aug 31, 2023
- Completion
- Nov 30, 2023
- Last update posted
- Jan 27, 2020
2016 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| OhioHealth | Columbus | Ohio | 43214 | — |
| Saint Thomas Heart | Nashville | Tennessee | 37205 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Swedish Health Services | Seattle | Washington | 98122 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02768402, 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 Jan 27, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02768402 live on ClinicalTrials.gov.