Cardiac Amyloidosis in Patients With Aortic Stenosis

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• Aortic Valve Stenosis 985

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 143 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Study population

Groups and cohorts

• ATTR-AS group

  Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

  Procedure: transcatheter aortic valve replacement (TAVR)

• AS group

  Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

  Procedure: transcatheter aortic valve replacement (TAVR)

Interventions

• Proceduretranscatheter aortic valve replacement (TAVR)

  TAVR 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).

Primary outcomes

1. All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with

   All-cause mortality is a statistical measure that counts all deaths in a specific population over a given time period, regardless of the cause of death.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

2. Composite endpoint of death and first hospitalization for heart failure

   In accordance with the Valve Academic Research Consortium-2 (VARC-2) criteria, the composite endpoints for early safety and clinical efficacy after transcatheter aortic valve replacement (TAVR) were evaluated.

   Time frame: 12 months

3. Change in serum transthyretin (TTR) level from baseline

   At baseline, 1 month, 3 months, 6 months, 12 months, the serum TTR levels were measured to assess the changes compared to the baseline.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

Secondary outcomes

1. Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline

   NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

2. Change in New York Heart Association (NYHA) functional classification from baseline

   NYHA functional classification was assessed at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated. The assessment was based on the New York Heart Association Functional Classification Scale, which is a 4-level ordinal scale with a minimum value of Class Ⅰ and a maximum value of Class Ⅳ. For this scale, higher scores represent worse clinical outcomes: Class Ⅰ: No limitation of physical activity Class Ⅱ: Slight limitation of physical activity Class Ⅲ: Marked limitation of physical activity Class Ⅳ: Unable to carry on any physical activity without symptoms

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

3. Change in quality of life from baseline

   In this study, the Minnesota Living With Heart Failure Questionnaire (MLHFQ) was used to assess patients' quality of life at baseline, 6 months, and 12 months. The MLHFQ corresponds to the full name Minnesota Living With Heart Failure Questionnaire, a disease-specific tool for evaluating heart failure-related quality of life. This scale has a total score range of 0 (minimum) to 105 (maximum). A higher total score reflects more severe quality of life impairment (i.e., worse outcome), while a lower score indicates better physical and psychological well-being in patients with heart failure.

   Time frame: baseline, 6 months, and 12 months

4. Change in Left Ventricular Ejection Fraction (LVEF) from baseline

   LVEF changes were evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

Other outcomes

1. Ventricular remodeling indices

   Cardiac Magnetic Resonance (CMR) was used to assess patients' ventricular function and structure at baseline and 12 months.

   Time frame: at baseline and 12 months

2. Echocardiographic indices

   Echocardiography was used to assess ventricular systolic function at baseline, 1 month, 3 months, 6 months, and 12 months.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

3. Change in cardiac troponin T (cTnT) level from baseline

   The change in cTnT level from baseline was evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.

   Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

4. 99Tcm-phosphonate (99Tcm-PYP) bone scan indices

   Patients underwent 99Tcm-PYP bone scans at baseline and 12 months, and the visual scoring grades and heart/contralateral lung (H/CL) ratios were recorded.

   Time frame: baseline, 12 months

5. Incidence of postprocedural complications

   Incidence of postprocedural complications, such as acute kidney injury, major bleeding, vascular complications, stroke, and new pacemaker implantation.

   Time frame: 1 month

6. Number of participants with adverse events (AEs) and serious adverse events (SAEs) within 12 months

   Number of participants with one or more AEs and SAEs within 12 months

   Time frame: 12 months

Individual participant data

Plan to share: No