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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
NCT02701283 · View on ClinicalTrials.gov ↗
Study Summary
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
Conditions Studied
Interventions
- DEVICE Medtronic Transcatheter Aortic Valve Replacement Systems
- DEVICE Surgical Aortic Valve Replacement (SAVR)
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla — La Jolla
- University of Southern California University Hospital — Los Angeles
- El Camino Hospital — Mountain View
- Mercy General Hospital — Sacramento
- Los Robles Hospital & Medical Center — Thousand Oaks
Florida
- Morton Plant Hospital — Clearwater
- Delray Medical Center — Delray Beach
- HealthPark Medical Center — Fort Myers
- University of Miami Hospital — Miami
- Tallahassee Research Institute, Inc. — Tallahassee
Arizona
- Abrazo Arizona Heart Hospital — Phoenix
Colorado
- University of Colorado Hospital — Aurora
Connecticut
- Yale New Haven Hospital — New Haven
Georgia
- Piedmont Atlanta Hospital — Atlanta
Illinois
- Loyola University Medical Center — Maywood
Indiana
- Saint Vincent Heart Center of Indiana — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,223 participants |
| Start Date | 2016-03 |
| Est. Completion | 2029-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02701283
The ClinicalTrials.gov registry entry for NCT02701283 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 2,223 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 Valve Stenosis appearing as the primary indexed condition, and to 2 interventions — of which Medtronic Transcatheter Aortic Valve Replacement Systems 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: NCT02701283 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT02701283 about?
NCT02701283 is a clinical study titled "Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients". The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative m...
What is the current status of trial NCT02701283?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,223 participants. The study started on 2016-03. Estimated completion is 2029-06.
What conditions does trial NCT02701283 study?
This clinical trial studies the following conditions: Aortic Valve 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 NCT02701283?
The interventions under investigation include: Medtronic Transcatheter Aortic Valve Replacement Systems (DEVICE), Surgical Aortic Valve Replacement (SAVR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02701283?
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 NCT02701283 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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