Clinical trial NCT05082454: Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
Official title: ASCEND - Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Disease
Keywords: aortic
valve
stenosis
thoracic
aneurysm
dissection
valved
conduit
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: at discharge to home or to rehabilitation
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Valve-related mortality
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Reoperation
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Explant
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Endocarditis
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Embolism
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Thromboembolism
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Bleeding
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Transient ischemic attack
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Stroke
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Ischemic stroke
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Hemorrhagic stroke
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Valve deterioration
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Non-structural dysfunction
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Valve thrombosis
timeFrame: 30-day, 1 year, 2 years, 3 years, 4 years, 5 years
measure: NYHA
timeFrame: 1 year, 3 years, 5 years
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center Main Hospital
state: Virginia
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle Freeman Hospital
Study officials:
affiliation: Policlinico S. Orsola-Malpighi
name: Davide Pacini, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: