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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: 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, 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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover (MHH)
  • Magdeburg, Germany, 39120
    • University Hospital Magdeburg
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola-Malpighi
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
• United Kingdom
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • London, United Kingdom, EC1A 7B
    • St Bartholomew's Hospital
  • Newcastle, United Kingdom, NE7 7DN
    • Newcastle Freeman Hospital
• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU Medical Center Main Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients (≥ 18 years of age) who either underwent (US only) or will be undergoing (Europe and US) implant of the On-X AAP for aortic valve and ascending aorta replacement and who meet the criteria listed below.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of in-house all-cause mortality	at discharge to home or to rehabilitation

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
Valve-related mortality	Rate of valve-related mortality	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Reoperation	Rate of patients with reoperation	30-day, 1 year, 2 years, 3 years, 4 years, 5 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
Endocarditis	Rate of patients with endocarditis	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Embolism	Rate of patients with embolism	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Thromboembolism	Rate of patients with peripheral thromboembolism	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Bleeding	Rate of patients with major bleeding	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Transient ischemic attack	Rate of patients with transient ischemic attack (TIA)	30-day, 1 year, 2 years, 3 years, 4 years, 5 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
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
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
Valve deterioration	Rate of patients with structural valve deterioration	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Non-structural dysfunction	Rate of patients with non-structural dysfunction	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
Valve thrombosis	Rate of patients with valve thrombosis	30-day, 1 year, 2 years, 3 years, 4 years, 5 years
NYHA	NYHA Functional Class	1 year, 3 years, 5 years

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Davide Pacini, Prof. Dr., Policlinico S. Orsola-Malpighi

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): February 6, 2024
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: aneurysm; aortic; valve; stenosis; dissection; thoracic; valved; conduit
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: ASCEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes