NCT07210541

Brief Summary

The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 12, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

August 1, 2025

Enrollment Period

7.5 years

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

Bioprosthesis FailureAllograft

Keywords

aortic valvebioprosthesisallograft

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Early cardio-vascular mortality

    30 days

Secondary Outcomes (6)

  • Mortality

    2 years

  • Mortality

    2 years

  • Structural valve deterioration

    2 years

  • Stroke

    2 years

  • Reoperation

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Stented biological prosthesis

Patients who underwent aortic valve replacement with stented biological valve

Procedure: aortic valve/root replacement

Allograft aortic root replacement

Patients who underwent allograft aortic root replacement

Interventions

aortic valve/root replacementPROCEDURE

Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft

Stented biological prosthesis

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with degenerative aortic valve disease, age 60-74 years

You may qualify if:

  • Patients with degenerative aortic valve disease not emendable for aortic valve repair
  • Elective surgery

You may not qualify if:

  • Left ventricle ejection fraction less than 40%
  • Redo surgery
  • Indication for concomitant mitral valve replacement
  • Aortic valve/root endocarditis
  • Severe COPD
  • Dialysis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

January 12, 2017

Primary Completion

June 30, 2024

Study Completion

September 29, 2025

Last Updated

October 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share