Clinical Trials in the UK / NCT05082454
Active, not recruiting
Observational
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
NCT05082454 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Aortic Valve Disease
Investigational drug(s) / intervention(s)
Open repair
Open repair: Open repair of the aortic heart valve and ascending thoracic aorta
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.
Eligibility
Inclusion Criteria:
* Patient ≥ 18 years of age at time of On-X AAP implant
* Patient understands and has signed the Informed Consent Form:
* Prior to implant of On-X AAP or
* Post implant (US only) or
* Patient died prior to enrollment (US only)
* Patient is willing and able to participate in follow-up
Exclusion Criteria:
* Patient unable to tolerate anticoagulation therapy
* Patient with active endocarditis at the time of his / her On-X AAP implant
* Patient participates / participated in another clinical investigation which may interfere / may have interfered with the effectiveness of anticoagulation therapy
* Patient has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
* Patients in which On-X AAP is implanted in combination with AMDS or FET
* Patient's life expectancy is less than 3 years in the opinion of the Investigator
Primary outcome measure(s)
- Mortality — at discharge to home or to rehabilitation
Rate of in-house all-cause mortality
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | |
| Baylor College of Medicine | Houston | Texas | |
| VCU Medical Center Main Hospital | Richmond | Virginia | |
| Medizinische Hochschule Hannover (MHH) | Hanover | Germany | |
| University Hospital Magdeburg | Magdeburg | Germany | |
| Policlinico S. Orsola-Malpighi | Bologna | Italy | |
| Hospital Germans Trias i Pujol | Badalona | Spain | |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | |
| Castle Hill Hospital | Cottingham | United Kingdom | |
| St Bartholomew's Hospital | London | United Kingdom | |
| Newcastle Freeman Hospital | Newcastle | United Kingdom |
Other trials for the same condition
Valved Graft PMCF Study
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05082454 on ClinicalTrials.gov ↗ ← All trials in the UK