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NCT01675440 · ClinicalTrials.gov registry 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
A clinical trial of Severe Aortic Stenosis, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- 782
- Enrollment target
- 20
- Study locations
NCT01675440: Active study of Severe Aortic Stenosis, sponsored by Medtronic Cardiovascular.
NCT01675440 is a study of Severe Aortic Stenosis that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 782 participants. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675440, a study of Severe Aortic Stenosis, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- 782 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
All-cause Mortality or Major Stroke
Conditions Studied
Interventions
- DEVICE Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Study Locations (20)
California
- Kaiser Permanente - Los Angeles Medical Center - Los Angeles
- University of Southern California University Hospital - Los Angeles
- VA Palo Alto Health Care System - Palo Alto
Connecticut
- Hartford Hospital - Hartford
- Yale New Haven Hospital - New Haven
Florida
- University of Miami Health System / Jackson Memorial Hospital - Miami
- Mount Sinai Medical Center - Miami Beach
Georgia
- Piedmont Heart Institute - Atlanta
- Saint Joseph's Hospital of Atlanta - Atlanta
Michigan
- University of Michigan Health Systems - Ann Arbor
- Detroit Medical Center Cardiovascular Institute - Detroit
Arizona
- Banner Good Samaritan - Phoenix
District of Columbia
- Washington Hospital Center / Georgetown Hospital - Washington D.C.
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 782 participants |
| Start Date | 2012-08 |
| Est. Completion | 2026-01 |
What the registry record for NCT01675440 still lists
NCT01675440 is an observational study that tracks outcomes without assigning an intervention. The registered 782 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Severe Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) is the first listed.
NCT01675440 names 20 study sites across 14 states, led by California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT01675440 about?
NCT01675440 is a clinical study titled "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". 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 ...
What is the current status of trial NCT01675440?
This trial is currently active not recruiting. The enrollment target is 782 participants. The study started on 2012-08. Estimated completion is 2026-01.
What conditions does trial NCT01675440 study?
This clinical trial studies the following conditions: Severe Aortic Stenosis.
What interventions are being tested in trial NCT01675440?
The interventions under investigation include: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (DEVICE).
Who is sponsoring clinical trial NCT01675440?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01675440 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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