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NCT01586910 · ClinicalTrials.gov registry record · NA
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).
A NA study of Severe Aortic Stenosis, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 1,746
- Enrollment target
- 20
- Study locations
NCT01586910: Active NA study of Severe Aortic Stenosis, sponsored by Medtronic Cardiovascular.
NCT01586910 is a NA study of Severe Aortic Stenosis that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 1,746 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01586910, a NA study of Severe Aortic Stenosis, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,746 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
Conditions Studied
Interventions
- DEVICE Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- PROCEDURE Surgical Aortic Valve Replacement (SAVR)
- DEVICE Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Study Locations (20)
California
- Cedars-Sinai Medical Center - Hollywood
- Scripps Green Hospital - La Jolla
- Keck Medical Center of USC - Los Angeles
- El Camino Hospital - Mountain View
- VA Palo Alto Health Care System - Palo Alto
- Southern California Permenente Medical Group - Pasadena
- Stanford University Medical Center - Stanford
Florida
- Morton Plant Hospital - Clearwater
- University of Miami - Coral Gables
- Delray Medical Center - Delray Beach
Connecticut
- Hartford Hospital - Hartford
- Yale New Haven Hospital - New Haven
Georgia
- Emory University - Atlanta
- Piedmont Healthcare, Inc. - Atlanta
Arizona
- Banner Good Samaritan Medical Center - Phoenix
District of Columbia
- Washington Hospital Center - Washington D.C.
Hawaii
- The Queen's Medical Center - Honolulu
Illinois
- Loyola University of Chicago - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,746 participants |
| Start Date | 2012-04 |
| Est. Completion | 2026-11 |
| Phase | NA |
What the registry record for NCT01586910 still lists
NCT01586910 is an interventional study that assigns participants to a tested intervention. Its 1,746 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Severe Aortic Stenosis appearing as the primary indexed condition, and to 3 interventions - of which Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) is the first listed.
NCT01586910 names 20 study sites across 10 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01586910 about?
NCT01586910 is a clinical study titled "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).". 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 Med...
What is the current status of trial NCT01586910?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,746 participants. The study started on 2012-04. Estimated completion is 2026-11.
What conditions does trial NCT01586910 study?
This clinical trial studies the following conditions: Severe Aortic Stenosis.
What interventions are being tested in trial NCT01586910?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01586910?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01586910 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.
Learn More About Clinical Trials
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Where NCT01586910's enrollment target sits among peer trials
1,746 62nd of 2000 higher than 1,939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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