PROTECTED TAVR: Stroke PROTECTion With SEntinel During Tr... | NCT04149535

Label	Type	Description	Intervention Names
TAVR with Sentinel	Experimental	Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.	Device: Sentinel® Cerebral Protection System
TAVR without Sentinel	No Intervention	Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

Name	Type	Description	Arm Group Labels	Other Names
Sentinel® Cerebral Protection System	Device	cerebral embolic protection system	TAVR with Sentinel

Measure	Description	Time Frame
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.	<=72 hours

Name	Affiliation	Role
Samir Kapadia, MD	The Cleveland Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tucson Medical Center		Tucson	Arizona	85712	United States
Cedars Sinai Medical Center

PubMed Identifier	Type	Citation	Retractions
39471309	Derived	Makkar RR, Gupta A, Waggoner TE, Horr S, Karha J, Satler L, Stoler RC, Alvarez J, Sakhuja R, MacDonald L, Modolo R, Leon MB, Linke A, Kapadia SR. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):17-24. doi: 10.1001/jamacardio.2024.4278.
36121045

ID	Title	Description
FG000	TAVR With Sentinel	Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system
FG001	TAVR Without Sentinel

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 6, 2019

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrioventricular block complete	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00086 affected1,501 at risk EG00192 affected1,499 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00041 affected1,501 at risk EG00129 affected1,499 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00015 affected1,501 at risk EG00114 affected1,499 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,501 at risk EG0016 affected1,499 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,501 at risk EG0016 affected1,499 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected1,501 at risk EG0016 affected1,499 at risk
Bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,501 at risk EG0017 affected1,499 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,501 at risk EG0013 affected1,499 at risk
Atrioventricular block	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,501 at risk EG0015 affected1,499 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected1,501 at risk EG0013 affected1,499 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,501 at risk EG0014 affected1,499 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,501 at risk EG0013 affected1,499 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0016 affected1,499 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,501 at risk EG0012 affected1,499 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0012 affected1,499 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,501 at risk EG0011 affected1,499 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0013 affected1,499 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0012 affected1,499 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0011 affected1,499 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0011 affected1,499 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Nodal rhythm	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Prosthetic cardiac valve thrombosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Right ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Bundle branch block	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Defect conduction intraventricular	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Myocardial haemorrhage	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Myocardial rupture	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Torsade de pointes	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,501 at risk EG00118 affected1,499 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,501 at risk EG00113 affected1,499 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0014 affected1,499 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected1,501 at risk EG0011 affected1,499 at risk
Embolic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Dementia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Disturbance in attention	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Lacunar infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0009 affected1,501 at risk EG00115 affected1,499 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0006 affected1,501 at risk EG00111 affected1,499 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0012 affected1,499 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0013 affected1,499 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Aortic annulus rupture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Aortic pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Device deployment issue	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Femoral nerve injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected1,501 at risk EG0018 affected1,499 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,501 at risk EG0013 affected1,499 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0014 affected1,499 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0011 affected1,499 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0014 affected1,499 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0012 affected1,499 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Aortic intramural haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Aortic rupture	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Shock	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Haemodynamic instability	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Haemorrhage	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Hypertensive urgency	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Hypoperfusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Catheter site haemorrhage	General disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected1,501 at risk EG0016 affected1,499 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0014 affected1,499 at risk
Catheter site haematoma	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0014 affected1,499 at risk
Device embolisation	General disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0011 affected1,499 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0012 affected1,499 at risk
Calcinosis	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Extravasation	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00012 affected1,501 at risk EG00110 affected1,499 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0012 affected1,499 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0012 affected1,499 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected1,501 at risk EG0017 affected1,499 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0011 affected1,499 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected1,501 at risk EG0016 affected1,499 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected1,501 at risk EG0015 affected1,499 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0012 affected1,499 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Delirium	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG00010 affected1,501 at risk EG00110 affected1,499 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0011 affected1,499 at risk
Device dislocation	Product Issues	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0013 affected1,499 at risk
Device failure	Product Issues	MedDRA 21.1	Systematic Assessment	EG0003 affected1,501 at risk EG0012 affected1,499 at risk
Device leakage	Product Issues	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Device malfunction	Product Issues	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0010 affected1,499 at risk
Lead dislodgement	Product Issues	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0012 affected1,499 at risk
Corona virus infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0012 affected1,499 at risk
Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected1,501 at risk EG0011 affected1,499 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Cardiovascular function test abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Troponin increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Diplopia	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Retinal artery occlusion	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected1,501 at risk EG0010 affected1,499 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected1,501 at risk EG0011 affected1,499 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	TAVR With Sentinel	Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system
BG001	TAVR Without Sentinel	Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TAVR With Sentinel	Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Sentinel® Cerebral Protection System: cerebral embolic protection system	11	1,501	285	1,501	0	1,501
EG001	TAVR Without Sentinel	Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.	7	1,499	315	1,499	0	1,499