The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures

Table 3 Study assessment schedule

Item	Screening/Baseline	Procedure	Hospital discharge	30 Days (+ 14 Days)	12 months (± 30 days)	Annual visits (to 10 years)
Informed consent, eligibility criteria, demographics, medical history, and risk factors, clinical assessment	X
Vital signs	X		X	X	X	X
Anticoagulant and/or antiplatelet medication	X		X	X	X	X
Blood tests^a	X^,		X	X	X	X
Procedural details of implantation and concomitant procedures		X
Intensive Care Unit (ICU management			X
Hospitalization data			X
Pain score assessment (visual analogue scale)			X^b	X^b
Echocardiography^c	X	X	X	X	X	X
Computed tomography^d	X	X	X	X	X	X
Electrocardiogram	X		X	X	X	X
NYHA class	X		X	X	X	X
QoL questionnaire^e	X			X	X
Serious adverse events		X	X	X	X	X
Device deficiencies		X	X	X	X	X
Accessories deficiencies		X

^aWhite blood cell, red blood cell, hemoglobin, hematocrit, platelets, serum lactate dehydrogenase, haptoglobin, reticulocyte, plasma free hemoglobin, serum creatinine (preoperatively and at discharge visit only), and international normalized ratio/quick. Plasma free hemoglobin will be collected only at sites that have the local capabilities of performing the evaluation. Blood tests baseline ideally be taken on admission, but in any case, not ≥ 7 days before the procedure
^bIdeally pain score assessment should be collected and entered at post-operative on day 1, day 3, at discharge, and 30 days postoperative
^cIncluding collection of images for analysis by Core Lab 3D TEE or 3D TTE images in accordance to standard of care
^dComputed tomography is optional; only when done as standard of care
^eKCCQ-12 questionnaire for all the subjects. EQ-5D-5L questionnaire also to be completed by participants implanted with Perceval Plus

ISSN: 1749-8090