Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement (DURABLE-AORTIC)

May 14, 2025 updated by: Roberto Lorusso, Maastricht University Medical Center
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht UMC+ METC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Description

Inclusion Criteria:

  • - Age ≥ 18 years; 9
  • Patients who underwent isolated aortic and mitral valve replacement for stenosis or regurgitation
  • Signed informed consent, inclusive of release of medical information.

Exclusion Criteria:

  • - Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
  • Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
  • Previous cardiac surgery of any kind;
  • Surgery for acute endocarditis
  • Surgery for Type A aortic dissection
  • Participation in another clinical trial that could interfere with the endpoints of this study.
  • Pregnant or breastfeeding at time of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or a
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study
Procedure: Aortic valve replacement

All operations were performed through median longitudinal sternotomy or mini-sternotomy.

8 Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. The removal of the calcified cusps and the decalcification of the annulus was performed according to traditional techniques. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic valve deterioration and degenration
Time Frame: 10-15 years
Echocardiographic analisys with multiparametric datas will be used. From quantitative to qualitative.
10-15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 15 years
Longitudinal analysis will be used to establish the surival rate at long term.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 2023-0326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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