Clinical Trial

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

Study acronym: DURABLE-AORTIC
Enrolling by Invitation
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Record status
This record was last updated May 15, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-30.
Trial Details
NCT Number NCT06964035
Lead Sponsor Maastricht University Medical Center
Conditions Aortic Bioprosthesis Degeneration
Enrollment 10,000 participants
Start Date 2024-01-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-15