Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
Public ClinicalTrials.gov record NCT01586910. 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
Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
Study identification
- NCT ID
- NCT01586910
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,746 participants
Conditions and interventions
Conditions
Interventions
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Device
- Surgical Aortic Valve Replacement (SAVR) Procedure
- Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) Device
Device · Procedure
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
- Apr 2012 (Actual)
- Primary completion
- Jul 2018 (Actual)
- Completion
- Nov 2026 (Estimated)
- Last update posted
- Jun 24, 2026
2012 – 2026
United States locations
- U.S. sites
- 65
- U.S. states
- 30
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | — |
| Cedars-Sinai Medical Center | Hollywood | California | 90048 | — |
| Scripps Green Hospital | La Jolla | California | 92037 | — |
| Keck Medical Center of USC | Los Angeles | California | 90033 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| Southern California Permenente Medical Group | Pasadena | California | 91101 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520-8047 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| University of Miami | Coral Gables | Florida | 33146 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| Piedmont Healthcare, Inc. | Atlanta | Georgia | 30309 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Loyola University of Chicago | Maywood | Illinois | 60153 | — |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | — |
| Iowa Heart Center / Mercy Medical Center | West Des Moines | Iowa | 50266 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| The Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Beth Israel Deaconess Medical Center, Inc. | Boston | Massachusetts | 02215 | — |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109-5864 | — |
| Detroit Medical Center | Detroit | Michigan | 48201-2018 | — |
| Henry Ford | Detroit | Michigan | 48202 | — |
| St. John Hospital & Medical Center | Detroit | Michigan | 48236 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| Abbott NW - MN Heart Institute Foundation | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic - St. Mary's Hospital | Rochester | Minnesota | 55905 | — |
| Saint Luke's Hospital/MAHI | Kansas City | Missouri | 64111 | — |
| Alegent Creighton Health Research Center | Omaha | Nebraska | 68124 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Carolinas HealthCare System | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| The OhioHealth Research Institute | Columbus | Ohio | 43214 | — |
| Oklahoma Heart Institute | Oklahoma City | Oklahoma | 73120 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | — |
| Stern Cardiovascular | Memphis | Tennessee | 38120 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| The Methodist DeBakey Heart & Vascular Center | Houston | Texas | 77030 | — |
| The Heart Hospital - Baylor Plano | Plano | Texas | 75093 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Vermont | Burlington | Vermont | 05401 | — |
| Sentara Cardiovascular | Norfolk | Virginia | 23507 | — |
| Bon Secours St. Mary's Hospital | Richmond | Virginia | 23226 | — |
| Aurora St. 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 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01586910, 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 Jun 24, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01586910 live on ClinicalTrials.gov.