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Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
NCT02322840 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DEVICE Twelve TMVR Implant
- DEVICE Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Study Locations (20)
New York
- NYU Langone Medical Center - PILOT — New York
- The Mount Sinai Hospital (New York NY) - EFS — New York
- The Mount Sinai Hospital (New York NY) - PILOT — New York
- New York-Presbyterian Hospital Columbia University Medical Center - EFS — New York
- New York-Presbyterian Hospital Columbia University Medical Center - PILOT — New York
Michigan
- University of Michigan Health System - University Hospital - PILOT — Ann Arbor
- Corewell Health - EFS — Grand Rapids
Minnesota
- Abbott Northwestern Hospital - EFS — Minneapolis
- Abbott Northwestern Hospital - PILOT — Minneapolis
Texas
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT — Dallas
- Houston Methodist Hospital - PILOT — Houston
Arizona
- Abrazo Arizona Heart Hospital - EFS — Phoenix
California
- Cedars-Sinai Medical Center - PILOT — Los Angeles
Georgia
- Piedmont Atlanta Hospital - PILOT — Atlanta
Illinois
- Northwestern Memorial Hospital - PILOT — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2015-04 |
| Est. Completion | 2028-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02322840
The ClinicalTrials.gov registry entry for NCT02322840 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 2 interventions — of which Twelve TMVR Implant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02322840 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Michigan, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02322840 about?
NCT02322840 is a clinical study titled "Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System". 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 Syst...
What is the current status of trial NCT02322840?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 128 participants. The study started on 2015-04. Estimated completion is 2028-12.
What conditions does trial NCT02322840 study?
This clinical trial studies the following conditions: Mitral Valve Insufficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02322840?
The interventions under investigation include: Twelve TMVR Implant (DEVICE), Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02322840?
This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02322840 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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