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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
Sponsor
JOTEC GmbH
Phase
Observational
Started
2021-10-20
Last updated
2025-02-05

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Trial sites (11)

FacilityCityRegionStatus
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

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