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

Aortic Valve Disease Clinical Trial

— ASCEND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082454
• Other study ID #: ASCEND
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Disease

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