eligible for enrollment into THAOS:
1. Evidence of a personally signed and dated informed consent document indicating that
the participant (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
2. Males and females 18 years of age.
3. Confirmed genotyped TTR mutation with or without a diagnosis of ATTR, or wild-type TTR
amyloidosis. Confirmation of wild-type TTR amyloidosis will be determined by genotyped
confirmation that patient does not possess a known mutation in TTR gene (ie, is a
carrier of wild-type allele only) via genetic testing and one of the following set of
criteria (A, B, or C):
1. Evidence of cardiac involvement by echocardiogram as defined by mean left
ventricle wall thickness of >12 mm, and presence of amyloid in cardiac biopsy
tissue confirmed as TTR amyloid by mass spectrometry or immunohistochemistry; or
2. Evidence of cardiac involvement by echocardiogram as defined by mean left
ventricle wall thickness of >12 mm, and presence of amyloid in non-cardiac tissue
confirmed as TTR amyloid by mass spectrometry or immunohistochemistry; or
3. Evidence of cardiac involvement by echocardiogram as defined by mean left
ventricle wall thickness of >12 mm, no evidence of primary (light chain)
amyloidosis, and presence of amyloid in cardiac tissue indirectly confirmed by
scintigraphy with a "bone seeking tracer" eg, 99mTC-DPD
[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid], 99mTC- PYP
[Pyrophosphate], and 99mTC-HMDP [hydroxymethylene diphosphonate] with Perugini
grade greater than or equal to 2.
Participant presenting with any of the following will not be included in THAOS:
1. Participant has primary or secondary amyloidosis.