Status:
NOT_YET_RECRUITING
Cardiac Amyloidosis in Patients With Aortic Stenosis
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Aortic Stenosis
Transthyretin Amyloid Cardiomyopathy
Eligibility:
All Genders
65-85 years
Brief Summary
This study intends to conduct a prospective observation to investigate the prevalence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS), compare the clinical characteristics between pa...
Detailed Description
Amyloid infiltration involving the aortic valve may cause endothelial damage, which in turn accelerates calcification and leads to the development or exacerbation of aortic stenosis (AS). Previous stu...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥ 65 years and ≤ 85 years;
- Patients with moderate-to-severe degenerative aortic stenosis (AS) who are hospitalized and scheduled to undergo transcatheter aortic valve replacement (TAVR);
- Patients who voluntarily sign the Informed Consent Form (ICF) and are able to comply with the study-specified treatment plan, follow-up visits, laboratory tests, and other requirements.
Exclusion
- Aortic stenosis (AS) caused by congenital diseases or rheumatic immune diseases;
- Severe renal impairment, chronic dialysis, or unresolved acute kidney injury after transcatheter aortic valve replacement (TAVR);
- Terminal-stage diseases with an expected life span of \< 6 months;
- Participation in other ongoing investigational studies of drugs or medical devices that have not yet been completed;
- Patients who are unable to attend the follow-up visits scheduled in the study;
- Failure to undergo TAVR surgery, transfer to surgical treatment, or in-hospital death.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT07170306
Start Date
October 1 2025
End Date
May 31 2028
Last Update
September 12 2025
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