🏛️ Verified NIH Record • Updated 2025-02-03
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP) (NCT05082454)
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: JOTEC GmbH
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (7 items).
Location: Geisinger Health System — Danville, Pennsylvania
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- Geisinger Health System — Danville, Pennsylvania
- Baylor College of Medicine — Houston, Texas
- VCU Medical Center Main Hospital — Richmond, Virginia
- 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,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.