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NCT03200574 · ClinicalTrials.gov registry record · NA
Behavior of Valve Leaflets Following Aortic Valve Implant
A NA study of Aortic Valve Replacement, sponsored by Corcym S.r.l.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 11
- Study locations
NCT03200574: Completed NA study of Aortic Valve Replacement, sponsored by Corcym S.r.l.
NCT03200574 is a NA study of Aortic Valve Replacement that has completed, run by Corcym S.r.l. The registered enrollment target is 88 participants, below the 387-participant average among 5 other Aortic Valve Replacement trials with a reported enrollment target (77% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03200574, a NA study of Aortic Valve Replacement, has completed, sponsored by Corcym S.r.l.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
Primary Outcome
Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 4D Cardiac CT Scan
- DEVICE LivaNova Bioprothetic Aortic Valve Implant
Study Locations (11)
Quebec
- Montreal Heart Institute - Montreal
- Universite Laval - Québec
Indiana
- St. Vincent Cardiovascular Research Institute - Indianapolis
Maine
- Maine Medical Center - Scarborough
Maryland
- Washington Adventist Hospital - Takoma Park
Michigan
- Oakwood Hospital - Dearborn
Minnesota
- Mayo Clinic - Rochester
Missouri
- Missouri Baptist Hospital - St Louis
Tennessee
- Centennial - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2017-12-06 |
| Est. Completion | 2021-02-25 |
| Phase | NA |
What the finished NCT03200574 record still lists
NCT03200574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 387-participant average among 5 other Aortic Valve Replacement trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Aortic Valve Replacement appearing as the primary indexed condition, and to 2 interventions - of which 4D Cardiac CT Scan is the first listed.
NCT03200574 lists 11 locations in 10 states (Quebec, Indiana, Maine).
Frequently Asked Questions
What is clinical trial NCT03200574 about?
NCT03200574 is a clinical study titled "Behavior of Valve Leaflets Following Aortic Valve Implant". This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
What is the current status of trial NCT03200574?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2017-12-06. Estimated completion is 2021-02-25.
What conditions does trial NCT03200574 study?
This clinical trial studies the following conditions: Aortic Valve Replacement.
What interventions are being tested in trial NCT03200574?
The interventions under investigation include: 4D Cardiac CT Scan (DIAGNOSTIC_TEST), LivaNova Bioprothetic Aortic Valve Implant (DEVICE).
Who is sponsoring clinical trial NCT03200574?
This trial is sponsored by Corcym S.r.l, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03200574 being conducted?
This trial has 11 study locations across Indiana, Maine, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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