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Medtronic CoreValve Evolut R U.S. Clinical Study
NCT02207569 · View on ClinicalTrials.gov ↗
Study Summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
Conditions Studied
Interventions
- DEVICE CoreValve Evolut R TAVR system
Study Locations (20)
New York
- New York Langone Medical Center — New York
- The Mount Sinai Medical Center — New York
- Columbia University Medical Center — New York
- St. Francis Hospital — Roslyn
Michigan
- University of Michigan Health Systems — Ann Arbor
- Detroit Medical Center Cardiovascular Institute — Detroit
- Spectrum Health — Grand Rapids
Pennsylvania
- University of Pittsburg Medical Center — Pittsburgh
- Pinnacle Health — Wormleysburg
Arizona
- Banner Good Samaritan Medical Center — Phoenix
California
- University of Southern California — Los Angeles
Connecticut
- Yale New Haven Hospital — New Haven
District of Columbia
- Washington Hospital Center/Medstar — Washington D.C.
Indiana
- St. Vincent Heart Center of Indiana/The Care Group, LLC — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2014-08 |
| Est. Completion | 2020-10-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02207569
The ClinicalTrials.gov registry entry for NCT02207569 describes a study currently listed as completed. 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 241 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 Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention — of which CoreValve Evolut R TAVR system 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: NCT02207569 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Michigan, Pennsylvania. 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 NCT02207569 about?
NCT02207569 is a clinical study titled "Medtronic CoreValve Evolut R U.S. Clinical Study". The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
What is the current status of trial NCT02207569?
This trial is currently completed. It is a NA study. The enrollment target is 241 participants. The study started on 2014-08. Estimated completion is 2020-10-28.
What conditions does trial NCT02207569 study?
This clinical trial studies the following conditions: Aortic Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02207569?
The interventions under investigation include: CoreValve Evolut R TAVR system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02207569?
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 NCT02207569 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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