.

Details of studies included in data analysis

Development data set
Study	OFISSER	Italian ClinicalService	CONNECT
Design	Observational	Observational	Randomized
Centres	Multiple, USA	Multiple, Italy	Multiple, USA
Main inclusion	CRT-D device for 6 months	CRT-D device	CRT or ICD device
Main exclusion	None	None	Permanent AF chronic warfarin Life expectancy <15 months
Inclusion for analysis	First 269 patients enrolled in study	OptiVol alerts turned OFF	CRT-D device Control arm
Access to data	Yes	Yes	Yes
Audible or remote care alerts	No	No	No
Validation data set
Study	PARTNERS-HF	FAST	PRECEDE-HF	SENSE-HF
Design	Observational	Observational	Randomized	Observational
Centres	Multiple, USA	Multiple, USA	Multiple, USA	Multiple, Europe, Asia
Main inclusion	CRT-D device	CRT-D device or ICD device with EF <35% and NYHA class III or IV	CRT-D or ICD device with HF event in last 12 months	CRT-D or ICD device with HF event in last 12 months
Main exclusion	Permanent AF CAI Heart transplant Renal disease	Heart transplant Severe chronic obstructive pulmonary disease PAH Life expectancy <6 months	Heart transplant CAI or MI Renal insufficiency	Heart transplant Severe chronic obstructive pulmonary disease PAH Renal insufficiency
Inclusion for analysis	OptiVol diagnostics	None	Control arm	First phase data (first 6 months)
Access to data	Yes	No	No	No
Audible or remote care alerts	No	No	No	No

PAH, pulmonary arterial hypertension; CAI, coronary artery intervention; MI, myocardial infarction.