Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesi⦠(NCT05082454) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
United States, Germany108 participantsStarted 2021-10-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient ā„ 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
What they're measuring
1
Mortality
Timeframe: at discharge to home or to rehabilitation