ClinicalTrials.gov record
Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement
ClinicalTrials.gov ID: NCT01675440
Public ClinicalTrials.gov record NCT01675440. 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.
ClinicalTrials.gov public records Last synced May 18, 2026, 11:13 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Medtronic CoreValve® U.S. Expanded Use Study
Study identification
- NCT ID
- NCT01675440
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- Medtronic Cardiovascular
- Industry
- Enrollment
- 782 participants
Conditions and interventions
Conditions
Interventions
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) 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
- Jul 31, 2012
- Primary completion
- Nov 30, 2016
- Completion
- Apr 7, 2025
- Last update posted
- May 4, 2026
2012 – 2025
United States locations
- U.S. sites
- 43
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Good Samaritan | Phoenix | Arizona | 85006 | — |
| Kaiser Permanente - Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| University of Southern California University Hospital | Los Angeles | California | 90033 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| Washington Hospital Center / Georgetown Hospital | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami Health System / Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 10029 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290-1090 | — |
| Iowa Heart Center | Des Moines | Iowa | 50314 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Cardiovascular Institute of the South/Terrebonne General | Houma | Louisiana | 70360 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109 | — |
| Detroit Medical Center Cardiovascular Institute | Detroit | Michigan | 48201 | — |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| The Mount Sinai Medical Center | New York | New York | 10029 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University - Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals - Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Medical Center - The Richard M. Ross Heart Hospital | Columbus | Ohio | 43210 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Pinnacle Health | Wormleysburg | Pennsylvania | 17101 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Texas Heart Institute at St. Luke's Episcopal Hospital | Houston | Texas | 77030 | — |
| The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center | Houston | Texas | 77030 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05458 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| St. Luke's Medical Center - Aurora Health Care | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01675440, 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 4, 2026 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01675440 live on ClinicalTrials.gov.