ECG Belt for CRT Response | NCT03504020

Label	Type	Description	Intervention Names
ECG Belt	Experimental	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.	Device: ECG Belt Research System
Control Arm	No Intervention	Standard CRT through 6 months follow-up.

Name	Type	Description	Arm Group Labels	Other Names
ECG Belt Research System	Device	The ECG Belt Research System is used to identify the best vector and programming parameters.	ECG Belt

Measure	Description	Time Frame
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.	Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.	baseline to 6 months

Name	Affiliation	Role
ECG Belt for CRT Response Clinical Research Specialist	Medtronic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Hartford Hospital		Hartford	Connecticut	06102	United States
Yale School of Medicine

PubMed Identifier	Type	Citation	Retractions
32537740	Result	Rickard J, Jackson K, Biffi M, Vernooy K, Bank A, Cerkvenik J, Ghosh S, Gold MR. The ECG Belt for CRT response trial: Design and clinical protocol. Pacing Clin Electrophysiol. 2020 Oct;43(10):1063-1071. doi: 10.1111/pace.13985. Epub 2020 Sep 1.
36442824	Result	Rickard J, Jackson K, Gold M, Biffi M, Ziacchi M, Silverstein J, Ramza B, Metzl M, Grubman E, Abben R, Varma N, Tabbal G, Jensen C, Wouters G, Ghosh S, Vernooy K; ECG Belt for CRT Response Study Group. Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization. Heart Rhythm. 2023 Apr;20(4):537-544. doi: 10.1016/j.hrthm.2022.11.015. Epub 2022 Nov 25.

ID	Title	Description
FG000	ECG Belt	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. > > ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
FG001	Control Arm

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form	May 2, 2019

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25	Systematic Assessment	EG0004 events3 affected200 at risk EG0010 events0 affected208 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected208 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Accelerated Idioventricular Rhythm	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected208 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0004 events2 affected200 at risk EG0015 events5 affected208 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Angina Pectoris	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected208 at risk
Arrhythmic Storm	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0003 events3 affected200 at risk EG0011 events1 affected208 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0006 events6 affected200 at risk EG0013 events3 affected208 at risk
Atrial Flutter	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected208 at risk
Atrial Thrombosis	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected208 at risk
Cardiac Failure	Cardiac disorders	MedDRA 25	Systematic Assessment	EG00011 events10 affected200 at risk EG00117 events7 affected208 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 25	Systematic Assessment	EG00010 events9 affected200 at risk EG0013 events2 affected208 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 25	Systematic Assessment	EG00010 events8 affected200 at risk EG0014 events4 affected208 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Cardiac Ventricular Thrombosis	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected208 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0003 events2 affected200 at risk EG0011 events1 affected208 at risk
Chronic Left Ventricular Failure	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected208 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0003 events2 affected200 at risk EG0011 events1 affected208 at risk
Pericarditis	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected208 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected208 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 25	Systematic Assessment	EG0006 events5 affected200 at risk EG0012 events2 affected208 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Cataract	Eye disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Retinal Detachment	Eye disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Ascites	Gastrointestinal disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected208 at risk
Asthenia	General disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected208 at risk
Inflammation	General disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Unevaluable Event	General disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Transplant Rejection	Immune system disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Bacteraemia	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Bronchiolitis	Infections and infestations	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Cellulitis	Infections and infestations	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Covid-19	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Endocarditis	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Endocarditis Enterococcal	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Enterococcal Bacteraemia	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Escherichia Infection	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Implant Site Infection	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Parotitis	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Pneumonia	Infections and infestations	MedDRA 25	Systematic Assessment	EG0003 events2 affected200 at risk EG0012 events2 affected208 at risk
Pneumonia Escherichia	Infections and infestations	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Sepsis	Infections and infestations	MedDRA 25	Systematic Assessment	EG0003 events3 affected200 at risk EG0011 events1 affected208 at risk
Septic Shock	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0014 events2 affected208 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected208 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Liver Function Test Increased	Investigations	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Gout	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Hyperglycaemic Hyperosmolar Nonketotic Syndrome	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events1 affected208 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Chest Wall Haematoma	Musculoskeletal and connective tissue disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Neuropathic Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Metastases To Peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Cauda Equina Syndrome	Nervous system disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected208 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Presyncope	Nervous system disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Syncope	Nervous system disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected208 at risk
Device Lead Damage	Product Issues	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Lead Dislodgement	Product Issues	MedDRA 25	Systematic Assessment	EG0004 events4 affected200 at risk EG0016 events6 affected208 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected208 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected208 at risk
End Stage Renal Disease	Renal and urinary disorders	MedDRA 25	Systematic Assessment	EG0003 events2 affected200 at risk EG0011 events1 affected208 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0003 events3 affected200 at risk EG0011 events1 affected208 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected208 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected208 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected208 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected208 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected208 at risk
Intermittent Claudication	Vascular disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 25	Systematic Assessment	EG0002 events1 affected200 at risk EG0010 events0 affected208 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 25	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected208 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	ECG Belt	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.> > ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
BG001	Control Arm	Standard CRT through 6 months follow-up.
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	ECG Belt	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.	12	200	68	200	0	200
EG001	Control Arm	Standard CRT through 9 months follow-up.	6	208	52	208	0	208