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

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study patients will be observed that receive an On-X AAP implant for the treatment of a diseased, damaged, or malfunctioning native or prosthetic heart valve. The On-X AAP will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the On-X AAP. Written informed consent of the patients for the use of their clinical records for study purposes will be obtained before their data will be collected in the PMCF study. In Europe, every patient will be enrolled prospectively prior to the intervention. In the US, patients can be enrolled retrospectively after the intervention or prospectively prior to the intervention. The data from patients who have died following their implant will be recorded in the database without the requirement for written informed consent after IRB approval. The period of data collection will be approximately 120 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient.

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

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Open repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Open repair|Open repair of the aortic heart valve and ascending thoracic aorta|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of in-house all-cause mortality | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | Rate of all-cause mortality | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Valve-related mortality | Rate of valve-related mortality | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Reoperation | Rate of patients with reoperation | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Explant | Rate of patients with explant of On-X AAP (including heart valve) | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Endocarditis | Rate of patients with endocarditis | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Embolism | Rate of patients with embolism | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Thromboembolism | Rate of patients with peripheral thromboembolism | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Bleeding | Rate of patients with major bleeding | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Transient ischemic attack | Rate of patients with transient ischemic attack (TIA) | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Stroke | Rate of patients with new stroke (ischemic and hemorrhagic) (mRS > mRS at baseline) | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Ischemic stroke | Rate of patients with new ischemic stroke (mRS > mRS at baseline) | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Hemorrhagic stroke | Rate of patients with new hemorrhagic stroke (mRS > mRS at baseline) | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Valve deterioration | Rate of patients with structural valve deterioration | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Non-structural dysfunction | Rate of patients with non-structural dysfunction | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| Valve thrombosis | Rate of patients with valve thrombosis | 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 
| NYHA | NYHA Functional Class | 1 year, 3 years, 5 years, 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic, valve, stenosis, thoracic, aneurysm, dissection, valved, conduit