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
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.
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Official title
Medtronic CoreValve® U.S. Expanded Use Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.
Study identification
- NCT ID
- NCT01675440
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 782 participants
Conditions and interventions
Conditions
Interventions
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
- Aug 2012 (Type not available)
- Primary completion
- Dec 2016 (Actual)
- Completion
- Apr 8, 2025 (Actual)
- Last update posted
- May 5, 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 5, 2026 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01675440 live on ClinicalTrials.gov.