Cardiac Amyloidosis in Patients With Aortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-85
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- transcatheter aortic valve replacement (TAVR)
Treatment groups
143 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov