Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry

Table 2 Data collection schedule

	Baseline/screening	Surgery	Discharge	3–6 months^a	Years 1–5
Signed informed consent	X
Medical history^b	X
Physical examination^c	X		X		X
ECG (12-lead)	X		X		X
Echocardiogram (TTE)	X		X		X
Core Lab echo					X^e
MSCT (if available)					X^f
NYHA class/CCS angina class	X			X	X
QoL questionnaire (SF-12 and KCCQ)	X			X	X^g
Anti-thromboembolic therapy and medications	X		X	X	X
Procedural information		X
Aetiology		X
SAE reporting		X	X	X	X
Discharge data			X
Rehospitalisation data^d				X	X
Return to work				X	X

CCS Canadian Cardiovascular Society, ECG Electrocardiogram, KCCQ Kansas City Cardiomyopathy Questionnaire, MSCT Multi-slice computed tomography, NYHA New York Heart Association, QoL Quality of life, SAE Serious adverse event(s), SF-12 Short Form-12 Health Survey, TTE Transthoracic echocardiogram
^aData captured over a telephone call
^bIncludes cardiovascular and non-cardiovascular conditions, prior cardiac interventions and surgeries
^cPhysical examination, includes height, weight and vital signs (blood pressure and heart rate)
^dIncludes re-interventions, potential valve-to-valve procedures, associated costs
^eSolely performed at 1-year and 5-years of follow-up
^fSolely documented at 5-years of follow-up
^gSolely performed at baseline, 3–6 months and years 1 and 3 of follow-up

ISSN: 1749-8090