Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Public ClinicalTrials.gov record NCT02701283. 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
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02701283
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,223 participants
Conditions and interventions
Conditions
Interventions
- Medtronic Transcatheter Aortic Valve Replacement Systems Device
- Surgical Aortic Valve Replacement (SAVR) Device
Device
Eligibility (public fields only)
- Age range
- Not listed
- 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 2016 (Type not available)
- Primary completion
- Apr 2021 (Actual)
- Completion
- Jun 2029 (Estimated)
- Last update posted
- May 7, 2026
2016 – 2029
United States locations
- U.S. sites
- 61
- U.S. states
- 32
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Abrazo Arizona Heart Hospital | Phoenix | Arizona | 85016 | — |
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | — |
| University of Southern California University Hospital | Los Angeles | California | 90033 | — |
| El Camino Hospital | Mountain View | California | 64040 | — |
| Mercy General Hospital | Sacramento | California | 95816 | — |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| HealthPark Medical Center | Fort Myers | Florida | 33908 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Tallahassee Research Institute, Inc. | Tallahassee | Florida | 32308 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Saint Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | — |
| Mercy Medical Center | Des Moines | Iowa | 50314 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Jewish Hospital | Louisville | Kentucky | 40202 | — |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mercy Hospital | Springfield | Missouri | 65806 | — |
| Saint Francis Hospital | East Hills | New York | 11548 | — |
| Saint Joseph's Hospital Health Center | Liverpool | New York | 13088 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| Strong Memorial Hospital | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Sanford Medical Center | Fargo | North Dakota | 58102 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| Geinsinger Medical Center | Danville | Pennsylvania | 17043 | — |
| Pinnacle Health | Harrisburg | Pennsylvania | 17043 | — |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | 15232 | — |
| Paramount Heart | Villanova | Pennsylvania | 19085 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75204 | — |
| Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Methodist Hospital San Antonio | San Antonio | Texas | 78229 | — |
| University Hospital Salt Lake City Utah | Salt Lake City | Utah | 84132 | — |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Saint Mary's Hospital | Richmond | Virginia | 23226 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| Aurora Saint Luke's Medical Center | 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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02701283, 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 May 7, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02701283 live on ClinicalTrials.gov.