Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Public ClinicalTrials.gov record NCT02322840. 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
An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Study identification
- NCT ID
- NCT02322840
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- Twelve TMVR Implant Device
- Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System Device
Device
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
- Mar 31, 2015
- Primary completion
- Aug 31, 2022
- Completion
- Nov 30, 2028
- Last update posted
- Jan 13, 2026
2015 – 2028
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Abrazo Arizona Heart Hospital - EFS | Phoenix | Arizona | 85016 | — |
| Cedars-Sinai Medical Center - PILOT | Los Angeles | California | 90048 | — |
| Piedmont Atlanta Hospital - PILOT | Atlanta | Georgia | 30309 | — |
| Northwestern Memorial Hospital - PILOT | Chicago | Illinois | 60208 | — |
| University of Michigan Health System - University Hospital - PILOT | Ann Arbor | Michigan | 48109 | — |
| Corewell Health - EFS | Grand Rapids | Michigan | 49503 | — |
| Abbott Northwestern Hospital - EFS | Minneapolis | Minnesota | 55407 | — |
| Abbott Northwestern Hospital - PILOT | Minneapolis | Minnesota | 55407 | — |
| Barnes Jewish Hospital - PILOT | St Louis | Missouri | 63110 | — |
| NYU Langone Medical Center - PILOT | New York | New York | 10016 | — |
| The Mount Sinai Hospital (New York NY) - EFS | New York | New York | 10029 | — |
| The Mount Sinai Hospital (New York NY) - PILOT | New York | New York | 10029 | — |
| New York-Presbyterian Hospital Columbia University Medical Center - EFS | New York | New York | 10032 | — |
| New York-Presbyterian Hospital Columbia University Medical Center - PILOT | New York | New York | 10032 | — |
| Oregon Health & Science University Hospital - EFS | Portland | Oregon | 97239 | — |
| UPMC Pinnacle Harrisburg Campus - EFS | Wormleysburg | Pennsylvania | 17043 | — |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT | Dallas | Texas | 75246 | — |
| Houston Methodist Hospital - PILOT | Houston | Texas | 77030 | — |
| University of Virginia Medical Center - EFS | Charlottesville | Virginia | 22908 | — |
| Aurora Saint Luke's Medical Center - EFS | Milwaukee | Wisconsin | 53215 | — |
| Aurora Saint Lukes Medical Center - PILOT | 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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02322840, 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 13, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02322840 live on ClinicalTrials.gov.