Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
Public ClinicalTrials.gov record NCT03539458. 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
Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Study identification
- NCT ID
- NCT03539458
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 11 participants
Conditions and interventions
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
- Oct 10, 2018 (Actual)
- Primary completion
- Nov 29, 2019 (Actual)
- Completion
- Jun 18, 2024 (Actual)
- Last update posted
- Nov 18, 2024
2018 – 2024
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
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 NCT03539458, 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 Nov 18, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03539458 live on ClinicalTrials.gov.