NCT05082454

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
36mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
5 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Oct 2021Mar 2029

First Submitted

Initial submission to the registry

September 28, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Expected
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

September 28, 2021

Last Update Submit

February 3, 2025

Conditions

Aortic Valve Disease

Keywords

aorticvalvestenosisthoracicaneurysmdissectionvalvedconduit

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Rate of in-house all-cause mortality

    at discharge to home or to rehabilitation

Secondary Outcomes (16)

  • All-cause Mortality

    30-day, 1 year, 2 years, 3 years, 4 years, 5 years

  • Valve-related mortality

    30-day, 1 year, 2 years, 3 years, 4 years, 5 years

  • Reoperation

    30-day, 1 year, 2 years, 3 years, 4 years, 5 years

  • Explant

    30-day, 1 year, 2 years, 3 years, 4 years, 5 years

  • Endocarditis

    30-day, 1 year, 2 years, 3 years, 4 years, 5 years

  • +11 more secondary outcomes

Interventions

Open repairDEVICE

Open repair of the aortic heart valve and ascending thoracic aorta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

VCU Medical Center Main Hospital

Richmond, Virginia, 23298, United States

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

University Hospital Magdeburg

Magdeburg, 39120, Germany

Location

Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7B, United Kingdom

Location

Newcastle Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve DiseaseConstriction, PathologicAneurysm

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Davide Pacini, Prof. Dr.

    Policlinico S. Orsola-Malpighi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 19, 2021

Study Start

October 20, 2021

Primary Completion

February 6, 2024

Study Completion (Estimated)

March 31, 2029

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)US(3)ES(2)GB(3)DE(2)