Closure of Atrial Septal Defects With the AMPLATZER Septa... | NCT00650936

Status Module

Label	Type	Description	Intervention Names
AMPLATZER Septal Occluder	Other	Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).	Device: AMPLATZER Septal Occluder

Name	Type	Description	Arm Group Labels	Other Names
AMPLATZER Septal Occluder	Device	AMPLATZER Septal Occluder	AMPLATZER Septal Occluder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Subjects With Two-year Device-related Hemodynamic Compromise	The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.	24 months
Co-Primary Effectiveness Endpoint	The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair	24 months
Co-Primary Safety Endpoint	The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event	24 months

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Kaiser Permanente

PubMed Identifier	Type	Citation	Retractions
28801537	Derived	Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e004212. doi: 10.1161/CIRCINTERVENTIONS.116.004212.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AMPLATZER Septal Occluder	The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00021(0.3 to 83.6)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000649
Male	BG000351

Height

Mean

Full Range

centimeters

Title

Denominators

Categories

Title	Measurements
	BG000135.3(33.3 to 198.1)

Weight

Mean

Full Range

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00045(4.5 to 179.2)

Qp/Qs

The magnitude of a cardiac shunt is described using Qp/Qs (pulmonary flow/systemic flow).

Mean

Full Range

ratio

Title

Denominators

Categories

Title	Measurements
	BG0002.1(0.0 to 8.3)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Subjects With Two-year Device-related Hemodynamic Compromise

The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.

The analysis population for the primary efficacy endpoint was all subjects who either reached their two-year visit or had a device-related hemodynamic compromise event.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	AMPLATZER Septal Occluder	The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).

Units	Counts
Participants	OG000928

Title

Denominators

Categories

Title	Measurements
	OG0000.65(NA to 1.4)One-sided analysis conducted and reported in the final report

Primary

Co-Primary Effectiveness Endpoint

The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met:

Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair

The analysis population for the co-primary effectiveness endpoint was all subjects who either reached their two-year visit or demonstrated closure of the atrial septal defect prior to or at their 2-year visit.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	AMPLATZER Septal Occluder	The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).

Units	Counts
Participants	OG000

Primary

Co-Primary Safety Endpoint

The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event

The analysis population for the co-primary safety endpoint is all subjects who either reached their two-year visit or had a device or delivery system related adverse event prior to their 2-year visit.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	AMPLATZER Septal Occluder	The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
Abnormal Lab Value	General disorders	EG0001 events1 affected1,000 at risk
Acute Life Threatening Event	General disorders	EG0001 events1 affected1,000 at risk
Acute Subdural Hematoma	General disorders	EG0001 events1 affected1,000 at risk
Air Embolus	General disorders	EG0001 events1 affected1,000 at risk
Anemias	General disorders	EG0001 events1 affected1,000 at risk
Aortic Aneurysms	General disorders	EG0001 events1 affected1,000 at risk
Arteriovenous (AV) Fistula	General disorders	EG0001 events1 affected1,000 at risk
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	General disorders	EG0001 events1 affected1,000 at risk
Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm	General disorders	EG0001 events1 affected1,000 at risk
Atrial Fibrillation	General disorders	EG0006 events6 affected1,000 at risk
Atrial Flutter	General disorders	EG0003 events3 affected1,000 at risk
Bleeding	General disorders	EG0002 events2 affected1,000 at risk
Breath Holding Spell	General disorders	EG0001 events1 affected1,000 at risk
Cancer	General disorders	EG0001 events1 affected1,000 at risk
Cardiac Arrest	General disorders	EG0002 events2 affected1,000 at risk
Cardiac Erosion	General disorders	EG0002 events2 affected1,000 at risk
Chest Pain	General disorders	EG0002 events2 affected1,000 at risk
Chronic Obstructive Pulmonary Disease (COPD)	General disorders	EG0001 events1 affected1,000 at risk
Congestive Heart Failure	General disorders	EG0003 events3 affected1,000 at risk
Device Embolization	General disorders	EG0004 events4 affected1,000 at risk
Diabetes Mellitus	General disorders	EG0001 events1 affected1,000 at risk
Elective Procedure	General disorders	EG0002 events2 affected1,000 at risk
Elective Surgery	General disorders	EG0003 events3 affected1,000 at risk
Fever	General disorders	EG0001 events1 affected1,000 at risk
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block	General disorders	EG0001 events1 affected1,000 at risk
Gastroenteritis	General disorders	EG0001 events1 affected1,000 at risk
Headache	General disorders	EG0001 events1 affected1,000 at risk
Hematuria	General disorders	EG0001 events1 affected1,000 at risk
Hypotension	General disorders	EG0002 events2 affected1,000 at risk
Hypoxemia	General disorders	EG0001 events1 affected1,000 at risk
Migraine	General disorders	EG0002 events2 affected1,000 at risk
Numbness	General disorders	EG0001 events1 affected1,000 at risk
Palpitations	General disorders	EG0001 events1 affected1,000 at risk
Pericardial Effusion	General disorders	EG0004 events4 affected1,000 at risk
Pericarditis	General disorders	EG0001 events1 affected1,000 at risk
Pleural Effusion	General disorders	EG0001 events1 affected1,000 at risk
Pneumonia	General disorders	EG0001 events1 affected1,000 at risk
Presyncope	General disorders	EG0001 events1 affected1,000 at risk
ST Segment Changes	General disorders	EG0001 events1 affected1,000 at risk
SVC Syndrome	General disorders	EG0001 events1 affected1,000 at risk
Sepsis	General disorders	EG0001 events1 affected1,000 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	General disorders	EG0001 events1 affected1,000 at risk
Stridor	General disorders	EG0001 events1 affected1,000 at risk
Stroke	General disorders	EG0001 events1 affected1,000 at risk
Surgical Closure of ASD	General disorders	EG0007 events7 affected1,000 at risk
Syncope	General disorders	EG0001 events1 affected1,000 at risk
Tingling	General disorders	EG0001 events1 affected1,000 at risk
VASC Pseudoaneurysm	General disorders	EG0001 events1 affected1,000 at risk
Vaso Vagal Response	General disorders	EG0001 events1 affected1,000 at risk
Visual Disturbance	General disorders	EG0001 events1 affected1,000 at risk

Other Adverse Events

Term	Organ System	Statistical Information
AV Block	Cardiac disorders	EG0001 events1 affected1,000 at risk
Abdominal Pain	General disorders	EG00011 events10 affected1,000 at risk
Abdominal Coagulation Parameter	Blood and lymphatic system disorders	EG0001 events1 affected1,000 at risk
Abdominal Lab Value	General disorders	EG0003 events2 affected1,000 at risk
Accelerated Idioventricular Rhythm	Cardiac disorders	EG0001 events1 affected1,000 at risk
Accelerated Junctional Rhythm	Cardiac disorders	EG0001 events1 affected1,000 at risk
Acrocyanosis	Cardiac disorders	EG0001 events1 affected1,000 at risk
Acute Bronchitis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Acute Otitis Media	Ear and labyrinth disorders	EG0002 events2 affected1,000 at risk
Acute Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Allergic Drug Reaction	General disorders	EG0001 events1 affected1,000 at risk
Anesthesia Reaction	Injury, poisoning and procedural complications	EG0001 events1 affected1,000 at risk
Angina Pectoris	Cardiac disorders	EG0001 events1 affected1,000 at risk
Antidromic Reciprocating Tachycardia	Cardiac disorders	EG0001 events1 affected1,000 at risk
Antral Erosion	Gastrointestinal disorders	EG0001 events1 affected1,000 at risk
Aortic Root Dilation	Cardiac disorders	EG0001 events1 affected1,000 at risk
Aortic Valve Regurgitation and Insufficiency/Valvular Regurgitation Aortic Valve	Cardiac disorders	EG0001 events1 affected1,000 at risk
Apnea	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Arterial Hypertension/Hypertension	Vascular disorders	EG0005 events5 affected1,000 at risk
Arthritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected1,000 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected1,000 at risk
Atelectasis	Injury, poisoning and procedural complications	EG00015 events15 affected1,000 at risk
Atrial Ectopic Beats and Rhythm / Premature Atrial Beats and Contractions	Cardiac disorders	EG00024 events22 affected1,000 at risk
Atrial Escape Beat	Cardiac disorders	EG0001 events1 affected1,000 at risk
Atrial Fibrillation	Cardiac disorders	EG00012 events11 affected1,000 at risk
Atrial Flutter	Cardiac disorders	EG0007 events7 affected1,000 at risk
Atrial Tachycardia	Cardiac disorders	EG0006 events6 affected1,000 at risk
Aura	General disorders	EG0004 events4 affected1,000 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0004 events4 affected1,000 at risk
Bacteremia	Infections and infestations	EG0001 events1 affected1,000 at risk
Bacterial Infection of the Skin	Skin and subcutaneous tissue disorders	EG0002 events2 affected1,000 at risk
Behavioral Alterations	Psychiatric disorders	EG0001 events1 affected1,000 at risk
Biventricular Hypertrophy / Combined Ventricular Hypertrophy	Cardiac disorders	EG0002 events2 affected1,000 at risk
Bleeding	General disorders	EG00020 events19 affected1,000 at risk
Blurred Vision	Eye disorders	EG0002 events2 affected1,000 at risk
Borderline Prolongation of QT Interval	Cardiac disorders	EG0001 events1 affected1,000 at risk
Brachial Plexus Injury	Injury, poisoning and procedural complications	EG0001 events1 affected1,000 at risk
Broad QRS Complex Arrhythmias	Cardiac disorders	EG0001 events1 affected1,000 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected1,000 at risk
Bruise/Purpura Simplex	Injury, poisoning and procedural complications	EG00062 events59 affected1,000 at risk
Cardiomegaly	Cardiac disorders	EG0003 events2 affected1,000 at risk
Chest Pain	Respiratory, thoracic and mediastinal disorders	EG00096 events86 affected1,000 at risk
Chest Tightness	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected1,000 at risk
Cholecystitis	Hepatobiliary disorders	EG0003 events2 affected1,000 at risk
Chronic Renal Failure	Renal and urinary disorders	EG0001 events1 affected1,000 at risk
Common Cold / Upper Respiratory Tract Infection	Infections and infestations	EG0008 events8 affected1,000 at risk
Congestive Heart Failure	Cardiac disorders	EG0002 events2 affected1,000 at risk
Constipation	Gastrointestinal disorders	EG0003 events3 affected1,000 at risk
Coronary Artery Anomaly	Vascular disorders	EG0001 events1 affected1,000 at risk
Coronary Artery Disease	Vascular disorders	EG0002 events2 affected1,000 at risk
Cough	General disorders	EG0004 events4 affected1,000 at risk
Decreased Appetite	General disorders	EG0001 events1 affected1,000 at risk
Decreased Exercise Tolerance	General disorders	EG0001 events1 affected1,000 at risk
Deep Vein Thrombosis	Vascular disorders	EG0002 events2 affected1,000 at risk
Dehydration	General disorders	EG0002 events2 affected1,000 at risk
Dental Trauma	General disorders	EG0001 events1 affected1,000 at risk
Dermatitis	Skin and subcutaneous tissue disorders	EG0001 events1 affected1,000 at risk
Device Embolization	Injury, poisoning and procedural complications	EG0002 events2 affected1,000 at risk
Diarrhea	General disorders	EG0001 events1 affected1,000 at risk
Diastolic Dysfunction	Cardiac disorders	EG0001 events1 affected1,000 at risk
Difficulty Catching Breath	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Dilated Main Pulmonary Artery (MPA)	Vascular disorders	EG0001 events1 affected1,000 at risk
Discomfort	General disorders	EG0001 events1 affected1,000 at risk
Diverticulitis	Gastrointestinal disorders	EG0002 events2 affected1,000 at risk
Dizziness	General disorders	EG00017 events17 affected1,000 at risk
Drug Rash	Skin and subcutaneous tissue disorders	EG0003 events2 affected1,000 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG00018 events16 affected1,000 at risk
EKG Abnormalities	Cardiac disorders	EG0002 events1 affected1,000 at risk
Echo Finding	Cardiac disorders	EG0004 events4 affected1,000 at risk
Edema	General disorders	EG0005 events5 affected1,000 at risk
Elective Surgery	Surgical and medical procedures	EG0003 events3 affected1,000 at risk
Emesis / Vomiting	Gastrointestinal disorders	EG00025 events25 affected1,000 at risk
Enlarged or Dilated Left Atrium (LA)	Cardiac disorders	EG0001 events1 affected1,000 at risk
Epididymitis	Reproductive system and breast disorders	EG0001 events1 affected1,000 at risk
Epistaxis	General disorders	EG00019 events18 affected1,000 at risk
Fainting / Blackout	General disorders	EG0001 events1 affected1,000 at risk
Fatigue / General Fatigue	General disorders	EG0006 events6 affected1,000 at risk
Febrile Seizures	General disorders	EG0001 events1 affected1,000 at risk
Fever	General disorders	EG00012 events11 affected1,000 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	EG0001 events1 affected1,000 at risk
First Degree Heart / AV Block / Cardiac Arrhythmia / First Degree AV Block	Cardiac disorders	EG00010 events10 affected1,000 at risk
Foreign Bodies	General disorders	EG0001 events1 affected1,000 at risk
Fracture	Musculoskeletal and connective tissue disorders	EG0002 events2 affected1,000 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	EG0003 events3 affected1,000 at risk
Gastrointestinal Illness	Gastrointestinal disorders	EG0001 events1 affected1,000 at risk
General Malaise	General disorders	EG0001 events1 affected1,000 at risk
Head and Neck Abscesses	Skin and subcutaneous tissue disorders	EG0001 events1 affected1,000 at risk
Headache	General disorders	EG00056 events55 affected1,000 at risk
Heart Block	Cardiac disorders	EG0003 events3 affected1,000 at risk
Heart Failure	Cardiac disorders	EG0001 events1 affected1,000 at risk
Heart Murmur	Cardiac disorders	EG0001 events1 affected1,000 at risk
Heartburn	Gastrointestinal disorders	EG0002 events2 affected1,000 at risk
Hematochezia	Gastrointestinal disorders	EG0001 events1 affected1,000 at risk
Hematoma	General disorders	EG00027 events27 affected1,000 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Herpes Simplex	Infections and infestations	EG0001 events1 affected1,000 at risk
Hyperlipidemia	General disorders	EG0001 events1 affected1,000 at risk
Hypotension	Cardiac disorders	EG00010 events10 affected1,000 at risk
Hypothermia	General disorders	EG0001 events1 affected1,000 at risk
Incomplete Right Bundle Branch Block	Cardiac disorders	EG00017 events17 affected1,000 at risk
Increased Left Atrial Pressure	Cardiac disorders	EG0002 events2 affected1,000 at risk
Increased PR Interval	Cardiac disorders	EG0001 events1 affected1,000 at risk
Interventricular Conduction Delay	Cardiac disorders	EG0001 events1 affected1,000 at risk
Inverted T Wave	Cardiac disorders	EG0001 events1 affected1,000 at risk
Irregular Menstrual Period	General disorders	EG0001 events1 affected1,000 at risk
Irritability	General disorders	EG0001 events1 affected1,000 at risk
Junctional Escape Rhythm / Intermittent Junctional Rhythm	Cardiac disorders	EG0006 events6 affected1,000 at risk
Knee Pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected1,000 at risk
Lacerations	General disorders	EG0001 events1 affected1,000 at risk
Left Axis Deviation	Cardiac disorders	EG0003 events3 affected1,000 at risk
Left Ventricular Hypertrophy (by EKG)	Cardiac disorders	EG0001 events1 affected1,000 at risk
Left Ventricular Hypertrophy (by Echo)	Cardiac disorders	EG0004 events4 affected1,000 at risk
Lightheadedness	General disorders	EG0004 events4 affected1,000 at risk
Long Q-T	Cardiac disorders	EG0001 events1 affected1,000 at risk
Low Back Pain	Cardiac disorders	EG0001 events1 affected1,000 at risk
Low/ Coronary Atrial Rhythm	Cardiac disorders	EG0007 events7 affected1,000 at risk
Lower Left Lobe Infiltrate	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Macular Degeneration	Eye disorders	EG0001 events1 affected1,000 at risk
Melena	Gastrointestinal disorders	EG0003 events2 affected1,000 at risk
Mid-Sternal Chest Pressure	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected1,000 at risk
Migraine	General disorders	EG00029 events27 affected1,000 at risk
Mitral Valve Prolapse	Cardiac disorders	EG0002 events2 affected1,000 at risk
Mitral Valve Regurgitation / Mitral Insufficiency	Cardiac disorders	EG0007 events7 affected1,000 at risk
Multiple Calcified Granulomata in the Lung Fields	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0006 events5 affected1,000 at risk
Nausea	General disorders	EG00012 events12 affected1,000 at risk
Nickel Allergy	General disorders	EG0001 events1 affected1,000 at risk
Non-Cardiac Chest Pain	General disorders	EG0006 events5 affected1,000 at risk
Non-Specific EKG Change	Cardiac disorders	EG0002 events2 affected1,000 at risk
Numbness	General disorders	EG0006 events6 affected1,000 at risk
Obstructive Sleep Apnea	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected1,000 at risk
Orthostatic Hypertension	Cardiac disorders	EG0004 events4 affected1,000 at risk
Otitis Media	Ear and labyrinth disorders	EG0002 events2 affected1,000 at risk
Overhydration	General disorders	EG0001 events1 affected1,000 at risk
Pain	General disorders	EG00014 events14 affected1,000 at risk
Palpitations	Cardiac disorders	EG00053 events50 affected1,000 at risk
Panic Attack	Psychiatric disorders	EG0001 events1 affected1,000 at risk
Paresthesia	Nervous system disorders	EG0001 events1 affected1,000 at risk
Paroxysmal Atrial Fibrillation	Cardiac disorders	EG0001 events1 affected1,000 at risk
Paroxysmal Atrial Tachycardia	Cardiac disorders	EG0001 events1 affected1,000 at risk
Paroxysmal Supraventricular Tachycardia	Cardiac disorders	EG0002 events2 affected1,000 at risk
Pericardial Effusion	Cardiac disorders	EG00027 events27 affected1,000 at risk
Pericarditis	Cardiac disorders	EG0002 events2 affected1,000 at risk
Peripheral Vascular Disease	Vascular disorders	EG0001 events1 affected1,000 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0007 events6 affected1,000 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	EG0005 events4 affected1,000 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0004 events3 affected1,000 at risk
Premature Ventricular Contraction	Cardiac disorders	EG0008 events8 affected1,000 at risk
Presyncope	Cardiac disorders	EG0001 events1 affected1,000 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected1,000 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected1,000 at risk
Pulmonary Nodule	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Pulmonary Venous Congestion	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Rash	Skin and subcutaneous tissue disorders	EG0003 events3 affected1,000 at risk
Regular Narrow QRS Tachycardia / Supraventricular Tachycardias	Cardiac disorders	EG0001 events1 affected1,000 at risk
Residual Interatrial Communication	Cardiac disorders	EG0001 events1 affected1,000 at risk
Residual Shunt	Cardiac disorders	EG0001 events1 affected1,000 at risk
Respiratory Illness	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Right Atrial Enlargement	Cardiac disorders	EG0003 events3 affected1,000 at risk
Right Axis Deviation	Cardiac disorders	EG0007 events7 affected1,000 at risk
Right Bundle Branch Block / Complete Right Bundle Branch Block	Cardiac disorders	EG0003 events3 affected1,000 at risk
Right Ventricular Conduction Delay	Cardiac disorders	EG0004 events4 affected1,000 at risk
Right Ventricular Hypertrophy	Cardiac disorders	EG0004 events4 affected1,000 at risk
Rotator Cuff Tear	Musculoskeletal and connective tissue disorders	EG0002 events2 affected1,000 at risk
ST Segment Changes	Cardiac disorders	EG0001 events1 affected1,000 at risk
ST-T-Wave Abnormality	Cardiac disorders	EG0003 events3 affected1,000 at risk
Seizure / Convulsions Epilepsy	Nervous system disorders	EG0002 events2 affected1,000 at risk
Sinus Arrhythmias	Cardiac disorders	EG0007 events7 affected1,000 at risk
Sinus Bradycardia / Sinus Bradycardia (Cardiac Arrhythmia)	Cardiac disorders	EG00023 events23 affected1,000 at risk
Sinus Tachycardia	Cardiac disorders	EG00015 events15 affected1,000 at risk
Sinusitis	General disorders	EG0002 events2 affected1,000 at risk
Skin Lesions	Skin and subcutaneous tissue disorders	EG0001 events1 affected1,000 at risk
Snoring	General disorders	EG0001 events1 affected1,000 at risk
Sore Throat	General disorders	EG0004 events4 affected1,000 at risk
Strep Throat	General disorders	EG0002 events2 affected1,000 at risk
Stroke	Vascular disorders	EG0001 events1 affected1,000 at risk
Swelling	General disorders	EG0001 events1 affected1,000 at risk
Syncope	Cardiac disorders	EG0003 events3 affected1,000 at risk
T-Wave Abnormalities	Cardiac disorders	EG0001 events1 affected1,000 at risk
T-Wave Inversion	Cardiac disorders	EG0001 events1 affected1,000 at risk
Tachycardia	Cardiac disorders	EG0002 events2 affected1,000 at risk
Tachypnea	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected1,000 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0001 events1 affected1,000 at risk
Thrombus	Cardiac disorders	EG0001 events1 affected1,000 at risk
Tingling	Nervous system disorders	EG0001 events1 affected1,000 at risk
Transient Ischemic Attack	Vascular disorders	EG0001 events1 affected1,000 at risk
Tremor	Nervous system disorders	EG0002 events2 affected1,000 at risk
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve	Cardiac disorders	EG0002 events2 affected1,000 at risk
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	Cardiac disorders	EG0002 events2 affected1,000 at risk
Ureteral Dysfunction	Renal and urinary disorders	EG0001 events1 affected1,000 at risk
Urinary Calculi	Renal and urinary disorders	EG0001 events1 affected1,000 at risk
VASC Bleeding	Vascular disorders	EG0002 events2 affected1,000 at risk
VASC Bruise	Vascular disorders	EG0001 events1 affected1,000 at risk
VASC Hematoma	Vascular disorders	EG0005 events5 affected1,000 at risk
VASC Pain	Vascular disorders	EG0005 events5 affected1,000 at risk
VASC Pseudoaneurysm	Vascular disorders	EG0002 events2 affected1,000 at risk
Vaso Vagal Response	Nervous system disorders	EG0003 events3 affected1,000 at risk
Vertigo	Ear and labyrinth disorders	EG0005 events5 affected1,000 at risk
Viral Syndrome	Infections and infestations	EG0001 events1 affected1,000 at risk
Other	General disorders	EG0002 events2 affected1,000 at risk

ID	Term
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies