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NCT05082454 · ClinicalTrials.gov registry record
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
A clinical trial of Aortic Valve Disease, sponsored by JOTEC.
- Active
- Registry status
- 108
- Enrollment target
- 11
- Study locations
NCT05082454: Active study of Aortic Valve Disease, sponsored by JOTEC.
NCT05082454 is a study of Aortic Valve Disease that is active but no longer recruiting, run by JOTEC. The registered enrollment target is 108 participants, below the 18,610-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05082454, a study of Aortic Valve Disease, is active but no longer recruiting, sponsored by JOTEC.
- ACTIVE NOT RECRUITING
- Registry status
- 108 participants
- Enrollment target
- 11
- Study locations
Study Summary
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
Primary Outcome
Rate of in-house all-cause mortality
Conditions Studied
Interventions
- DEVICE Open repair
Study Locations (11)
Other
- Medizinische Hochschule Hannover (MHH) - Hanover
- University Hospital Magdeburg - Magdeburg
- Policlinico S. Orsola-Malpighi - Bologna
- Hospital Germans Trias i Pujol - Badalona
- Hospital de la Santa Creu i Sant Pau - Barcelona
- Castle Hill Hospital - Cottingham
- St Bartholomew's Hospital - London
- Newcastle Freeman Hospital - Newcastle
Pennsylvania
- Geisinger Health System - Danville
Texas
- Baylor College of Medicine - Houston
Virginia
- VCU Medical Center Main Hospital - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2029-03-31 |
What the registry record for NCT05082454 still lists
NCT05082454 is an observational study that tracks outcomes without assigning an intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 18,610-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which Open repair is the first listed.
NCT05082454 lists 11 locations in 4 states (Other, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT05082454 about?
NCT05082454 is a clinical study titled "Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)". The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
What is the current status of trial NCT05082454?
This trial is currently active not recruiting. The enrollment target is 108 participants. The study started on 2021-10-20. Estimated completion is 2029-03-31.
What conditions does trial NCT05082454 study?
This clinical trial studies the following conditions: Aortic Valve Disease.
What interventions are being tested in trial NCT05082454?
The interventions under investigation include: Open repair (DEVICE).
Who is sponsoring clinical trial NCT05082454?
This trial is sponsored by JOTEC, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05082454 being conducted?
This trial has 11 study locations across Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05082454's enrollment target sits among peer trials
108 10th of 15 higher than 6 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease 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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