Post Market Clinical Follow-Up Study in Patients Treated with the On-X Ascending Aortic Prosthesis (AAP)
- Conditions
- Aortic Valve Disease
- Registration Number
- NCT05082454
- Lead Sponsor
- JOTEC GmbH
- Brief 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.
- Detailed Description
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, specifically allowing the use of clinical records for this observational study, will be obtained from every patient in Europe and every patient that is alive in the US prior to data collection where required. 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 60 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient.
Echocardiography images at prior to discharge, at 12 months, 60 months will be evaluated by a CoreLab. All adverse events defined in the Clinical Event Committee (CEC) charter will be adjudicated by the CEC.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality at discharge to home or to rehabilitation Rate of in-house all-cause mortality
- Secondary Outcome Measures
Name Time Method All-cause Mortality 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of all-cause mortality
Valve-related mortality 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of valve-related mortality
Reoperation 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with reoperation
Explant 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with explant of On-X AAP (including heart valve)
Endocarditis 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with endocarditis
Embolism 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with embolism
Thromboembolism 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with peripheral thromboembolism
Bleeding 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with major bleeding
Transient ischemic attack 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with transient ischemic attack (TIA)
Stroke 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with new stroke (ischemic and hemorrhagic) (mRS \> mRS at baseline)
Ischemic stroke 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with new ischemic stroke (mRS \> mRS at baseline)
Hemorrhagic stroke 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with new hemorrhagic stroke (mRS \> mRS at baseline)
Valve deterioration 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with structural valve deterioration
Non-structural dysfunction 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with non-structural dysfunction
Valve thrombosis 30-day, 1 year, 2 years, 3 years, 4 years, 5 years Rate of patients with valve thrombosis
NYHA 1 year, 3 years, 5 years NYHA Functional Class
Trial Locations
- Locations (11)
Newcastle Freeman Hospital
🇬🇧Newcastle, United Kingdom
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Geisinger Health System
🇺🇸Danville, Pennsylvania, United States
VCU Medical Center Main Hospital
🇺🇸Richmond, Virginia, United States
University Hospital Magdeburg
🇩🇪Magdeburg, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom