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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03635424
The ClinicalTrials.gov registry entry for NCT03635424 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,813-participant average among 4 other Bicuspid Aortic Valve trials with a reported enrollment target (95% lower). The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.