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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05082454
Other study ID # ASCEND
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date March 31, 2029

Study information

Verified date January 2024
Source JOTEC GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 108
Est. completion date March 31, 2029
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Open repair
Open repair of the aortic heart valve and ascending thoracic aorta

Locations

Country Name City State
Germany Medizinische Hochschule Hannover (MHH) Hannover
Germany University Hospital Magdeburg Magdeburg
Italy Policlinico S. Orsola-Malpighi Bologna
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
United Kingdom Castle Hill Hospital Cottingham
United Kingdom St Bartholomew's Hospital London
United Kingdom Newcastle Freeman Hospital Newcastle
United States Geisinger Health System Danville Pennsylvania
United States Baylor College of Medicine Houston Texas
United States VCU Medical Center Main Hospital Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
JOTEC GmbH

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Rate of in-house all-cause mortality 30-day
Secondary All-cause Mortality Rate of 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
Secondary Valve-related mortality Rate of 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
Secondary Reoperation Rate of patients with reoperation 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary 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, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Endocarditis Rate of patients with endocarditis 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Embolism Rate of patients with embolism 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Thromboembolism Rate of patients with peripheral thromboembolism 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Bleeding Rate of patients with major bleeding 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Transient ischemic attack Rate of patients with transient ischemic attack (TIA) 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary 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, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary 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, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary 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, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Valve deterioration Rate of patients with structural valve deterioration 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary Non-structural dysfunction Rate of patients with 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
Secondary Valve thrombosis Rate of patients with valve thrombosis 30-day, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Secondary NYHA NYHA Functional Class 1 year, 3 years, 5 years, 10 years
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