. 2023 Jan 31;4(4):275–282. doi: 10.1016/j.hroo.2023.01.005

Table 1.

Schedule of events following SPIRIT guidelines

	Enrollment/baseline visit (within 30 d of procedure)	Procedure	Post–index procedure
			Predischarge	Therapy consolidation period			12 mo	24 mo
			Predischarge	1 mo	3 mo	6 mo	12 mo	24 mo
Enrollment	X
Eligibility screen	X
Informed consent	X
Assessments
Medication review	X			X	X	X	X	X
Symptom review	X			X	X	X	X	X
12-lead ECG	X		X	X	X	X	X	X
7-day heart rate monitoring	X					X	X	X
AEs (MAEs, AEs)		X	X	X	X	X	X	X
Exercise regimen^∗	X			X	X	X	X	X
TTE				X^†		X
6-min walk test	X					X	X	X
SAS assessment	X					X	X	X
SF-12	X					X	X	X

Unscheduled visits will include review of symptoms and medications, 12-lead ECG, MAE/AE assessment, and computed tomography/magnetic resonance imaging if clinical evidence of constrictive pericarditis and/or superior vena cava/inferior vena cava stenosis.

AE = adverse event; ECG = electrocardiogram, MAE = major adverse event; SAS = Self-Rating Anxiety Scale; SF-12 = 12-item Short Form Survey; SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials; TTE = transthoracic echocardiogram.

^∗

At physician’s discretion or standard of care.

^†

If symptoms suggestive of delayed pericardial effusion or pericarditis are reported (eg, chest pain, shortness of breath).