Representation of Cardiac Valvular Abornomality

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pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	VISIT
1	ABC	PR	ABC-456	1	TRANSTHORACIC ECHOCARDIOGRAPHY	BASELINE

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The transthoracic electrocardiography (TTE) produced images of the heart.

Rows 1-2:	I examined the TTE image of the heart (test location) and found calcified mitral valve annulus (result location).
Rows 3-4:	I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenotic.
Rows 5-6:	I examined the TTE image of the heart (test location) and regurgitation of blood in the mitral valve back into the left atrium.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUGRPID	TULNKID	TUTEST	TUORRES	TULOC	TUMETHOD	VISITNUM	VISIT	TUDTC	TURESLOC	TURESLOC Detail
1	ABC	TU	ABC-456	1	1	CAL 1	Calcification Indicator	Y	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
2	ABC	TU	ABC-456	2	1	CAL 1	Calcification Location Identification	Located	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	Mitral Valve Annulus
3	ABC	TU	ABC-456	3	2	STEN 1	Cardiac Valvular Stenosis Indicator	Y	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
4	ABC	TU	ABC-456	4	2	STEN 1	Cardiac Valvular Stenosis Location Identification	Located	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	Mitral Valve
5	ABC	TU	ABC-456	5	3	REGUR 1	Cardiac Valvular Regurgitation Indicator	Y	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27
6	ABC	TU	ABC-456	6	3	REGUR 1	Cardiac Valvular Regurgitation Location Identification	Located	HEART	TRANSTHORACIC ECHOCARDIOGRAPHY	1	BASELINE	2020-04-27	Mitral Valve	Into the left atrium

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Note these tests were originally created as a CVTEST, based on SDTMIG 3.4, this is considered as a grading scale and therefore should now be represented as CC/RS. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.

Row 1:	Mitral valve stenosis is moderate.
Row 2:	Mitral valve regurgitation is severe.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTEST	RSCAT	RSORRES	RSMETHOD	VISITNUM	VISIT	RSDTC
1	ABC	RS	ABC-456	1	REGUR 1	Cardiac Valvular Stenosis Severity	Baumgartner Valve Stenosis 2009	Moderate	TTE	1	BASELINE	2020-04-27
2	ABC	RS	ABC-456	2	STEN 1	Cardiac Valvular Regurgitation Severity	Zoghbi Severity of Native Valvular Regurgitation 2003	Severe	TTE	1	BASELINE	2020-04-27

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The below example shows how to represent calcification severity from a sponsor defined criteria using the CV domain. The Mitral Valve Annulus identified in TU is severely calcified.

cv.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	CVLNKID	CVTEST	CVCAT	CVORRES	CVMETHOD	VISITNUM	VISIT	RSDTC
1	ABC	CV	ABC-456	1	CAL 1	Calcification Severity	Sponsor-defined Criteria	Severe	TTE	1	BASELINE	2020-04-27

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