NCT05082454

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Open repair	Open repair of the aortic heart valve and ascending thoracic aorta

Timeline

• Start date: 2021-10-20
• Primary completion: 2024-02-06
• Completion: 2029-03-31
• First posted: 2021-10-19
• Last updated: 2025-02-05

Locations

11 sites across 5 countries: United States, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study