Expanded Clinical Study of the Tendyne Mitral Valve System
Public ClinicalTrials.gov record NCT02321514. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
Study identification
- NCT ID
- NCT02321514
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 191 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
- Nov 2014 (Actual)
- Primary completion
- Jul 2020 (Actual)
- Completion
- Apr 2025 (Actual)
- Last update posted
- Jul 17, 2025
2014 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health Scottsdale Shea Medical Center | Scottsdale | Arizona | 85260 | — |
| MedStar Washington Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plan Mease Health Care | Clearwater | Florida | 33756 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Northshore University Health System | Evanston | Illinois | 60201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Pinnacle Health - Harrisburg Hospital | Harrisburg | Pennsylvania | 17104 | — |
| Baylor Heart & Vascular Center | Dallas | Texas | 75226 | — |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02321514, 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 Jul 17, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02321514 live on ClinicalTrials.gov.