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NCT02088554 · ClinicalTrials.gov registry record · NA
PERIGON Pivotal Trial
A NA study of Aortic Stenosis, sponsored by Medtronic Cardiac Surgery.
- Active
- Registry status
- NA
- Development phase
- 1,312
- Enrollment target
- 20
- Study locations
NCT02088554: Active NA study of Aortic Stenosis, sponsored by Medtronic Cardiac Surgery.
NCT02088554 is a NA study of Aortic Stenosis that is active but no longer recruiting, run by Medtronic Cardiac Surgery. The registered enrollment target is 1,312 participants, roughly in line with the 1,312-participant average among 26 other Aortic Stenosis trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088554, a NA study of Aortic Stenosis, is active but no longer recruiting, sponsored by Medtronic Cardiac Surgery.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,312 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Primary Outcome
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events a
Conditions Studied
Interventions
- DEVICE Model 400 aortic valve bioprosthesis
Study Locations (20)
New York
- Maimonides Medical Center - Brooklyn
- The Mount Sinai Medical Center - New York
- New York-Presbyterian Hospital/Columbia University Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
- Riverside Methodist Hospital (OhioHealth) - Columbus
- ProMedica Toledo Hospital - Toledo
Texas
- Cardiothoracic and Vascular Surgeons (CTVS) - Austin
- Houston Methodist Hospital - Houston
California
- University of Southern California (USC) University Hospital - Los Angeles
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Hartford Hospital - Hartford
Florida
- University of Florida Shands - Gainesville
Georgia
- Piedmont Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,312 participants |
| Start Date | 2014-05-12 |
| Est. Completion | 2035-12-31 |
| Phase | NA |
What the registry record for NCT02088554 still lists
NCT02088554 is an interventional study that assigns participants to a tested intervention. Its 1,312 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,312-participant average among 26 other Aortic Stenosis trials with a reported enrollment target.
The record links to 1 condition, with Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Model 400 aortic valve bioprosthesis is the first listed.
NCT02088554 names 20 study sites across 15 states, led by New York, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT02088554 about?
NCT02088554 is a clinical study titled "PERIGON Pivotal Trial". To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
What is the current status of trial NCT02088554?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,312 participants. The study started on 2014-05-12. Estimated completion is 2035-12-31.
What conditions does trial NCT02088554 study?
This clinical trial studies the following conditions: Aortic Stenosis.
What interventions are being tested in trial NCT02088554?
The interventions under investigation include: Model 400 aortic valve bioprosthesis (DEVICE).
Who is sponsoring clinical trial NCT02088554?
This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02088554 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic 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 NCT02088554's enrollment target sits among peer trials
1,312 7th of 26 higher than 20 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic 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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