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

Sponsor

JOTEC GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05082454

Collaborator

(none)

150

Enrollment

Locations

149.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Device: Open repair

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 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 31, 2034

Outcome Measures

Primary Outcome Measures

Mortality [30-day]
Rate of in-house all-cause mortality

Secondary Outcome Measures

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]
Rate of all-cause mortality
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]
Rate of valve-related mortality
Reoperation [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with reoperation
Explant [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 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, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with endocarditis
Embolism [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with embolism
Thromboembolism [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with peripheral thromboembolism
Bleeding [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with major bleeding
Transient ischemic attack [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with transient ischemic attack (TIA)
Stroke [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 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, 6 years, 7 years, 8 years, 9 years, 10 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, 6 years, 7 years, 8 years, 9 years, 10 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, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with structural valve deterioration
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]
Rate of patients with non-structural dysfunction
Valve thrombosis [30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years]
Rate of patients with valve thrombosis
NYHA [1 year, 3 years, 5 years, 10 years]
NYHA Functional Class

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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