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OpenTrials
Enrolling by Invitation

NCT Number: NCT06964035

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht UMC+ METC

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aortic valve replacement

Procedure

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.

Primary outcomes

  1. Prosthetic valve deterioration and degenration

    Time frame: 10-15 years

    Echocardiographic analisys with multiparametric datas will be used. From quantitative to qualitative.

Secondary outcomes

  1. Survival

    Time frame: 15 years

    Longitudinal analysis will be used to establish the surival rate at long term.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: DURABLE-AORTIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.