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NCT02701283 · ClinicalTrials.gov registry record · NA
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
A NA study of Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 2,223
- Enrollment target
- 20
- Study locations
NCT02701283: Active NA study of Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular.
NCT02701283 is a NA study of Aortic Valve Stenosis that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 2,223 participants, above the 969-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (129% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02701283, a NA study of Aortic Valve Stenosis, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 2,223 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
Primary Outcome
Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).
Conditions Studied
Interventions
- DEVICE Medtronic Transcatheter Aortic Valve Replacement Systems
- DEVICE Surgical Aortic Valve Replacement (SAVR)
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla - La Jolla
- University of Southern California University Hospital - Los Angeles
- El Camino Hospital - Mountain View
- Mercy General Hospital - Sacramento
- Los Robles Hospital & Medical Center - Thousand Oaks
Florida
- Morton Plant Hospital - Clearwater
- Delray Medical Center - Delray Beach
- HealthPark Medical Center - Fort Myers
- University of Miami Hospital - Miami
- Tallahassee Research Institute, Inc. - Tallahassee
Arizona
- Abrazo Arizona Heart Hospital - Phoenix
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Yale New Haven Hospital - New Haven
Georgia
- Piedmont Atlanta Hospital - Atlanta
Illinois
- Loyola University Medical Center - Maywood
Indiana
- Saint Vincent Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,223 participants |
| Start Date | 2016-03 |
| Est. Completion | 2029-06 |
| Phase | NA |
What the registry record for NCT02701283 still lists
NCT02701283 is an interventional study that assigns participants to a tested intervention. Its 2,223 participants enrollment target places it among the larger protocols in the corpus, above the 969-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (129% higher).
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Transcatheter Aortic Valve Replacement Systems is the first listed.
NCT02701283 names 20 study sites across 12 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02701283 about?
NCT02701283 is a clinical study titled "Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients". The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative m...
What is the current status of trial NCT02701283?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,223 participants. The study started on 2016-03. Estimated completion is 2029-06.
What conditions does trial NCT02701283 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis.
What interventions are being tested in trial NCT02701283?
The interventions under investigation include: Medtronic Transcatheter Aortic Valve Replacement Systems (DEVICE), Surgical Aortic Valve Replacement (SAVR) (DEVICE).
Who is sponsoring clinical trial NCT02701283?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02701283 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Valve Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02701283's enrollment target sits among peer trials
2,223 3rd of 30 higher than 28 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis 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.
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