Cardiac Amyloidosis in Patients With Aortic Stenosis
- Sponsor
- Shanghai Zhongshan Hospital
- Study ID
- NCT07170306
- Status
- Not Yet Recruiting
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Conditions
- Aortic Stenosis
- Transthyretin Amyloid Cardiomyopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- transcatheter aortic valve replacement (TAVR) — PROCEDURETAVR is a minimally invasive cardiac interventional procedure that delivers a compressed artificial aortic valve to the diseased aortic valve site via peripheral blood vessels (e.g., the femoral artery) or the apex of the heart through a catheter, releases and deploys the valve to replace the original diseased valve leaflets, thereby restoring normal valve function and treating severe aortic stenosis (AS).
Study Details
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 patients with isolated AS and those with AS complicated by CA (CA-AS), and simultaneously explore the impact of transcatheter aortic valve replacement (TAVR) on serum transthyretin (TTR) levels in patients with AS complicated by transthyretin amyloidosis (ATTR-AS), as well as its influence on the treatment outcomes of patients with isolated AS and ATTR-AS.
Key Dates
- Start date
- Jan 31, 2026
- Status verified
- Jan 2026
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 143 participants (estimated)
Arms
- Arm: ATTR-AS groupPatients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.
- Arm: AS groupPatients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.
Primary Outcome Measure
All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with [ Time Frame: baseline, 1 month, 3 months, 6 months, and 12 months ]
Central Contacts
- Ming Li13564254007
- Dan Tian13916157135
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