Clinical trial NCT06964035: Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
Official title: Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aortic Bioprosthesis Degeneration
Keywords: aortic bioprosthesis
bioprosthesis degeneration
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prosthetic valve deterioration and degenration
timeFrame: 10-15 years
Secondary outcomes:
measure: Survival
timeFrame: 15 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+ METC
Study officials:
References: