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NCT03635424 · ClinicalTrials.gov registry record · NA
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
A NA study of Bicuspid Aortic Valve, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT03635424: Active NA study of Bicuspid Aortic Valve, sponsored by Medtronic Cardiovascular.
NCT03635424 is a NA study of Bicuspid Aortic Valve that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 150 participants, below the 2,813-participant average among 4 other Bicuspid Aortic Valve trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635424, a NA study of Bicuspid Aortic Valve, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Primary Outcome
Rate of of all-cause mortality or disabling stroke rate at 30 days
Conditions Studied
Interventions
- DEVICE Medtronic TAVR Systems
Study Locations (20)
Florida
- Morton Plant Hospital - Clearwater
- HealthPark Medical Center - Fort Myers
- Tallahassee Memorial Hospital - Tallahassee
New York
- North Shore University Hospital - Manhasset
- The Mount Sinai Hospital - New York
- Saint Francis Hospital - Roslyn
California
- Scripps Memorial Hospital La Jolla - La Jolla
- Los Robles Hospital & Medical Center - Thousand Oaks
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Michigan
- University of Michigan Health System - Ann Arbor
- Spectrum Health Hospital - Grand Rapids
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- OhioHealth Riverside Methodist Hospital - Columbus
Arizona
- Abrazo Arizona Heart Hospital - Phoenix
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2030-12 |
| Phase | NA |
What the registry record for NCT03635424 still lists
NCT03635424 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 2,813-participant average among 4 other Bicuspid Aortic Valve trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Bicuspid Aortic Valve appearing as the primary indexed condition, and to 1 intervention - of which Medtronic TAVR Systems is the first listed.
NCT03635424 names 20 study sites across 12 states, led by Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT03635424 about?
NCT03635424 is a clinical study titled "Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study". The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
What is the current status of trial NCT03635424?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2018-10-30. Estimated completion is 2030-12.
What conditions does trial NCT03635424 study?
This clinical trial studies the following conditions: Bicuspid Aortic Valve.
What interventions are being tested in trial NCT03635424?
The interventions under investigation include: Medtronic TAVR Systems (DEVICE).
Who is sponsoring clinical trial NCT03635424?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03635424 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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