Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)

Running, not enrolling

Conditions studied: Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT05082454

Run by

JOTEC GmbH

People needed

108

Starts

2021-10-20

Expected to finish

2029-03-31

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Geisinger Health System — Danville, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• VCU Medical Center Main Hospital — Richmond, Virginia, United States
• 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

Full record on ClinicalTrials.gov

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