Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00650936
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 51
• Arm: 1
• Duration (Months): 82
• Patients Per Site: 19.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

Condition or Disease	Intervention/Treatment	Phase
Atrial Septal Defect	Device: AMPLATZER Septal Occluder	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: AMPLATZER Septal Occluder 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; AMPLATZER Septal Occluder

Outcome Measures

Primary Outcome Measures

1. Percent of Subjects With Two-year Device-related Hemodynamic Compromise [24 months]

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

2. Co-Primary Effectiveness Endpoint [24 months]

   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

3. Co-Primary Safety Endpoint [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:

• is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),

• is willing and able to complete the follow-up requirements of this study, and

• signs the informed consent (or a legal representative signs the informed consent).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Kaiser Permanente	Los Angeles	California	United States	90027
3	Children's Hospital of Central California	Madera	California	United States	93636
4	Children's Hospital Oakland	Oakland	California	United States	94609
5	University of California, San Francisco	San Francisco	California	United States	94143
6	Aurora Denver Cardiology Associates	Aurora	Colorado	United States	80012
7	Medical Center of the Rockies	Loveland	Colorado	United States	80538
8	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
9	Washington Hospital Center	Washington	District of Columbia	United States	20010
10	Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
11	Jacksonville Pediatric Cardiovascular Center	Jacksonville	Florida	United States	32207
12	Miami Children's Hospital	Miami	Florida	United States	33165
13	Arnold Palmer Hospital for Children	Orlando	Florida	United States	32806
14	Tampa General Hospital	Tampa	Florida	United States	33609
15	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30341
16	Rush University Medical Center	Chicago	Illinois	United States	60612
17	Hope Children's Hospital	Oak Lawn	Illinois	United States	60453
18	Indiana University	Indianapolis	Indiana	United States	46202
19	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
20	University of Kentucky	Lexington	Kentucky	United States	40536
21	Children's Hospital of New Orleans	New Orleans	Louisiana	United States	70118
22	University of Michigan	Ann Arbor	Michigan	United States	48109
23	Children's Hospital of Michigan	Detroit	Michigan	United States	84201
24	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota	United States	55404
25	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
26	Washington University	Saint Louis	Missouri	United States	63110
27	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
28	Schneider Children's Hospital	New Hyde Park	New York	United States	11040
29	The New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
30	Children's Hospital of New York-Presbyterian	New York	New York	United States	10032
31	Children's Hospital at Strong	Rochester	New York	United States	14618
32	Sanger Heart & Vascular Institute/Carolinas Medical Center	Charlotte	North Carolina	United States	28203
33	East Carolina University	Greenville	North Carolina	United States	27834
34	Akron Children's Hospital	Akron	Ohio	United States	44308
35	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
36	The Children's Hospital at Cleveland Clinic	Cleveland	Ohio	United States	44195
37	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
38	The Children's Hospital	Oklahoma City	Oklahoma	United States	73104
39	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102
40	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
41	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania	United States	17043
42	Medical University of South Carolina	Charleston	South Carolina	United States	29425
43	LeBonheur Children's Hospital	Memphis	Tennessee	United States	38105
44	Vanderbilt University-Children's	Nashville	Tennessee	United States	37232
45	Vanderbilt University	Nashville	Tennessee	United States	37232
46	North Austin Medical Center	Austin	Texas	United States	78758
47	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78412
48	Universtiy of Virginia	Charlottesville	Virginia	United States	22908
49	INOVA Fairfax Hospital	Falls Church	Virginia	United States	22042
50	Sacred Heart Children's Hospital	Spokane	Washington	United States	99204
51	Aurora Health Care	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00650936
• Other Study ID Numbers: AGA-014
• First Posted: Apr 2, 2008
• Last Update Posted: Jul 9, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Abbott Medical Devices: Atrial; Septal; Defect
• Additional relevant MeSH terms: Heart Septal Defects; Heart Septal Defects, Atrial

Study Results

Participant Flow

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	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).
Period Title: Overall Study
STARTED	1000
COMPLETED	930
NOT COMPLETED	70

Baseline Characteristics

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	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).
Overall Participants	1000
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	21
Sex: Female, Male (Count of Participants)
Female	649 64.9%
Male	351 35.1%
Height (centimeters) [Mean (Full Range) ]
Mean (Full Range) [centimeters]	135.3
Weight (kilograms) [Mean (Full Range) ]
Mean (Full Range) [kilograms]	45
Qp/Qs (ratio) [Mean (Full Range) ]
Mean (Full Range) [ratio]	2.1

Outcome Measures

1. Primary Outcome

Title	Percent of Subjects With Two-year Device-related Hemodynamic Compromise
Description	The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	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).
Measure Participants	928
Number (95% Confidence Interval) [percentage of participants]	0.65 0.1%

2. Primary Outcome

Title	Co-Primary Effectiveness Endpoint
Description	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
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	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).
Measure Participants	987
Number (95% Confidence Interval) [percentage of participants]	97.87 9.8%

3. Primary Outcome

Title	Co-Primary Safety Endpoint
Description	The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	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).
Measure Participants	930
Number (95% Confidence Interval) [percentage of participants]	6.34 0.6%

Adverse Events

Arm/Group Title	AMPLATZER Septal Occluder
Arm/Group Description	Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body). AMPLATZER Septal Occluder: AMPLATZER Septal Occluder
All Cause Mortality
	AMPLATZER Septal Occluder
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AMPLATZER Septal Occluder
	Affected / at Risk (%)	# Events
Total	57/1000 (5.7%)
General disorders
Abnormal Lab Value	1/1000 (0.1%)	1
Acute Life Threatening Event	1/1000 (0.1%)	1
Acute Subdural Hematoma	1/1000 (0.1%)	1
Air Embolus	1/1000 (0.1%)	1
Anemias	1/1000 (0.1%)	1
Aortic Aneurysms	1/1000 (0.1%)	1
Arteriovenous (AV) Fistula	1/1000 (0.1%)	1
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	1/1000 (0.1%)	1
Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm	1/1000 (0.1%)	1
Atrial Fibrillation	6/1000 (0.6%)	6
Atrial Flutter	3/1000 (0.3%)	3
Bleeding	2/1000 (0.2%)	2
Breath Holding Spell	1/1000 (0.1%)	1
Cancer	1/1000 (0.1%)	1
Cardiac Arrest	2/1000 (0.2%)	2
Cardiac Erosion	2/1000 (0.2%)	2
Chest Pain	2/1000 (0.2%)	2
Chronic Obstructive Pulmonary Disease (COPD)	1/1000 (0.1%)	1
Congestive Heart Failure	3/1000 (0.3%)	3
Device Embolization	4/1000 (0.4%)	4
Diabetes Mellitus	1/1000 (0.1%)	1
Elective Procedure	2/1000 (0.2%)	2
Elective Surgery	3/1000 (0.3%)	3
Fever	1/1000 (0.1%)	1
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block	1/1000 (0.1%)	1
Gastroenteritis	1/1000 (0.1%)	1
Headache	1/1000 (0.1%)	1
Hematuria	1/1000 (0.1%)	1
Hypotension	2/1000 (0.2%)	2
Hypoxemia	1/1000 (0.1%)	1
Migraine	2/1000 (0.2%)	2
Numbness	1/1000 (0.1%)	1
Palpitations	1/1000 (0.1%)	1
Pericardial Effusion	4/1000 (0.4%)	4
Pericarditis	1/1000 (0.1%)	1
Pleural Effusion	1/1000 (0.1%)	1
Pneumonia	1/1000 (0.1%)	1
Presyncope	1/1000 (0.1%)	1
ST Segment Changes	1/1000 (0.1%)	1
SVC Syndrome	1/1000 (0.1%)	1
Sepsis	1/1000 (0.1%)	1
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	1/1000 (0.1%)	1
Stridor	1/1000 (0.1%)	1
Stroke	1/1000 (0.1%)	1
Surgical Closure of ASD	7/1000 (0.7%)	7
Syncope	1/1000 (0.1%)	1
Tingling	1/1000 (0.1%)	1
VASC Pseudoaneurysm	1/1000 (0.1%)	1
Vaso Vagal Response	1/1000 (0.1%)	1
Visual Disturbance	1/1000 (0.1%)	1
Other (Not Including Serious) Adverse Events
	AMPLATZER Septal Occluder
	Affected / at Risk (%)	# Events
Total	489/1000 (48.9%)
Blood and lymphatic system disorders
Abdominal Coagulation Parameter	1/1000 (0.1%)	1
Thrombocytopenia	1/1000 (0.1%)	1
Cardiac disorders
AV Block	1/1000 (0.1%)	1
Accelerated Idioventricular Rhythm	1/1000 (0.1%)	1
Accelerated Junctional Rhythm	1/1000 (0.1%)	1
Acrocyanosis	1/1000 (0.1%)	1
Angina Pectoris	1/1000 (0.1%)	1
Antidromic Reciprocating Tachycardia	1/1000 (0.1%)	1
Aortic Root Dilation	1/1000 (0.1%)	1
Aortic Valve Regurgitation and Insufficiency/Valvular Regurgitation Aortic Valve	1/1000 (0.1%)	1
Atrial Ectopic Beats and Rhythm / Premature Atrial Beats and Contractions	22/1000 (2.2%)	24
Atrial Escape Beat	1/1000 (0.1%)	1
Atrial Fibrillation	11/1000 (1.1%)	12
Atrial Flutter	7/1000 (0.7%)	7
Atrial Tachycardia	6/1000 (0.6%)	6
Biventricular Hypertrophy / Combined Ventricular Hypertrophy	2/1000 (0.2%)	2
Borderline Prolongation of QT Interval	1/1000 (0.1%)	1
Broad QRS Complex Arrhythmias	1/1000 (0.1%)	1
Cardiomegaly	2/1000 (0.2%)	3
Congestive Heart Failure	2/1000 (0.2%)	2
Diastolic Dysfunction	1/1000 (0.1%)	1
EKG Abnormalities	1/1000 (0.1%)	2
Echo Finding	4/1000 (0.4%)	4
Enlarged or Dilated Left Atrium (LA)	1/1000 (0.1%)	1
First Degree Heart / AV Block / Cardiac Arrhythmia / First Degree AV Block	10/1000 (1%)	10
Heart Block	3/1000 (0.3%)	3
Heart Failure	1/1000 (0.1%)	1
Heart Murmur	1/1000 (0.1%)	1
Hypotension	10/1000 (1%)	10
Incomplete Right Bundle Branch Block	17/1000 (1.7%)	17
Increased Left Atrial Pressure	2/1000 (0.2%)	2
Increased PR Interval	1/1000 (0.1%)	1
Interventricular Conduction Delay	1/1000 (0.1%)	1
Inverted T Wave	1/1000 (0.1%)	1
Junctional Escape Rhythm / Intermittent Junctional Rhythm	6/1000 (0.6%)	6
Left Axis Deviation	3/1000 (0.3%)	3
Left Ventricular Hypertrophy (by EKG)	1/1000 (0.1%)	1
Left Ventricular Hypertrophy (by Echo)	4/1000 (0.4%)	4
Long Q-T	1/1000 (0.1%)	1
Low Back Pain	1/1000 (0.1%)	1
Low/ Coronary Atrial Rhythm	7/1000 (0.7%)	7
Mitral Valve Prolapse	2/1000 (0.2%)	2
Mitral Valve Regurgitation / Mitral Insufficiency	7/1000 (0.7%)	7
Non-Specific EKG Change	2/1000 (0.2%)	2
Orthostatic Hypertension	4/1000 (0.4%)	4
Palpitations	50/1000 (5%)	53
Paroxysmal Atrial Fibrillation	1/1000 (0.1%)	1
Paroxysmal Atrial Tachycardia	1/1000 (0.1%)	1
Paroxysmal Supraventricular Tachycardia	2/1000 (0.2%)	2
Pericardial Effusion	27/1000 (2.7%)	27
Pericarditis	2/1000 (0.2%)	2
Premature Ventricular Contraction	8/1000 (0.8%)	8
Presyncope	1/1000 (0.1%)	1
Regular Narrow QRS Tachycardia / Supraventricular Tachycardias	1/1000 (0.1%)	1
Residual Interatrial Communication	1/1000 (0.1%)	1
Residual Shunt	1/1000 (0.1%)	1
Right Atrial Enlargement	3/1000 (0.3%)	3
Right Axis Deviation	7/1000 (0.7%)	7
Right Bundle Branch Block / Complete Right Bundle Branch Block	3/1000 (0.3%)	3
Right Ventricular Conduction Delay	4/1000 (0.4%)	4
Right Ventricular Hypertrophy	4/1000 (0.4%)	4
ST Segment Changes	1/1000 (0.1%)	1
ST-T-Wave Abnormality	3/1000 (0.3%)	3
Sinus Arrhythmias	7/1000 (0.7%)	7
Sinus Bradycardia / Sinus Bradycardia (Cardiac Arrhythmia)	23/1000 (2.3%)	23
Sinus Tachycardia	15/1000 (1.5%)	15
Syncope	3/1000 (0.3%)	3
T-Wave Abnormalities	1/1000 (0.1%)	1
T-Wave Inversion	1/1000 (0.1%)	1
Tachycardia	2/1000 (0.2%)	2
Thrombus	1/1000 (0.1%)	1
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve	2/1000 (0.2%)	2
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	2/1000 (0.2%)	2
Ear and labyrinth disorders
Acute Otitis Media	2/1000 (0.2%)	2
Otitis Media	2/1000 (0.2%)	2
Vertigo	5/1000 (0.5%)	5
Eye disorders
Blurred Vision	2/1000 (0.2%)	2
Macular Degeneration	1/1000 (0.1%)	1
Gastrointestinal disorders
Antral Erosion	1/1000 (0.1%)	1
Constipation	3/1000 (0.3%)	3
Diverticulitis	2/1000 (0.2%)	2
Emesis / Vomiting	25/1000 (2.5%)	25
Gastroesophageal Reflux Disease	3/1000 (0.3%)	3
Gastrointestinal Illness	1/1000 (0.1%)	1
Heartburn	2/1000 (0.2%)	2
Hematochezia	1/1000 (0.1%)	1
Melena	2/1000 (0.2%)	3
General disorders
Abdominal Pain	10/1000 (1%)	11
Abdominal Lab Value	2/1000 (0.2%)	3
Allergic Drug Reaction	1/1000 (0.1%)	1
Aura	4/1000 (0.4%)	4
Bleeding	19/1000 (1.9%)	20
Cough	4/1000 (0.4%)	4
Decreased Appetite	1/1000 (0.1%)	1
Decreased Exercise Tolerance	1/1000 (0.1%)	1
Dehydration	2/1000 (0.2%)	2
Dental Trauma	1/1000 (0.1%)	1
Diarrhea	1/1000 (0.1%)	1
Discomfort	1/1000 (0.1%)	1
Dizziness	17/1000 (1.7%)	17
Edema	5/1000 (0.5%)	5
Epistaxis	18/1000 (1.8%)	19
Fainting / Blackout	1/1000 (0.1%)	1
Fatigue / General Fatigue	6/1000 (0.6%)	6
Febrile Seizures	1/1000 (0.1%)	1
Fever	11/1000 (1.1%)	12
Foreign Bodies	1/1000 (0.1%)	1
General Malaise	1/1000 (0.1%)	1
Headache	55/1000 (5.5%)	56
Hematoma	27/1000 (2.7%)	27
Hyperlipidemia	1/1000 (0.1%)	1
Hypothermia	1/1000 (0.1%)	1
Irregular Menstrual Period	1/1000 (0.1%)	1
Irritability	1/1000 (0.1%)	1
Lacerations	1/1000 (0.1%)	1
Lightheadedness	4/1000 (0.4%)	4
Migraine	27/1000 (2.7%)	29
Nausea	12/1000 (1.2%)	12
Nickel Allergy	1/1000 (0.1%)	1
Non-Cardiac Chest Pain	5/1000 (0.5%)	6
Numbness	6/1000 (0.6%)	6
Overhydration	1/1000 (0.1%)	1
Pain	14/1000 (1.4%)	14
Sinusitis	2/1000 (0.2%)	2
Snoring	1/1000 (0.1%)	1
Sore Throat	4/1000 (0.4%)	4
Strep Throat	2/1000 (0.2%)	2
Swelling	1/1000 (0.1%)	1
Other	2/1000 (0.2%)	2
Hepatobiliary disorders
Cholecystitis	2/1000 (0.2%)	3
Infections and infestations
Bacteremia	1/1000 (0.1%)	1
Common Cold / Upper Respiratory Tract Infection	8/1000 (0.8%)	8
Herpes Simplex	1/1000 (0.1%)	1
Viral Syndrome	1/1000 (0.1%)	1
Injury, poisoning and procedural complications
Anesthesia Reaction	1/1000 (0.1%)	1
Atelectasis	15/1000 (1.5%)	15
Brachial Plexus Injury	1/1000 (0.1%)	1
Bruise/Purpura Simplex	59/1000 (5.9%)	62
Device Embolization	2/1000 (0.2%)	2
Musculoskeletal and connective tissue disorders
Arthritis	1/1000 (0.1%)	1
Back Pain	4/1000 (0.4%)	4
Fibromyalgia	1/1000 (0.1%)	1
Fracture	2/1000 (0.2%)	2
Knee Pain	1/1000 (0.1%)	1
Musculoskeletal Pain	5/1000 (0.5%)	6
Rotator Cuff Tear	2/1000 (0.2%)	2
Nervous system disorders
Paresthesia	1/1000 (0.1%)	1
Seizure / Convulsions Epilepsy	2/1000 (0.2%)	2
Tingling	1/1000 (0.1%)	1
Tremor	2/1000 (0.2%)	2
Vaso Vagal Response	3/1000 (0.3%)	3
Psychiatric disorders
Behavioral Alterations	1/1000 (0.1%)	1
Panic Attack	1/1000 (0.1%)	1
Renal and urinary disorders
Chronic Renal Failure	1/1000 (0.1%)	1
Ureteral Dysfunction	1/1000 (0.1%)	1
Urinary Calculi	1/1000 (0.1%)	1
Reproductive system and breast disorders
Epididymitis	1/1000 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis	1/1000 (0.1%)	1
Acute Pulmonary Edema	1/1000 (0.1%)	1
Apnea	1/1000 (0.1%)	1
Asthma	3/1000 (0.3%)	3
Bronchiolitis	1/1000 (0.1%)	1
Bronchitis	3/1000 (0.3%)	3
Chest Pain	86/1000 (8.6%)	96
Chest Tightness	4/1000 (0.4%)	4
Difficulty Catching Breath	1/1000 (0.1%)	1
Dyspnea	16/1000 (1.6%)	18
Hemoptysis	1/1000 (0.1%)	1
Lower Left Lobe Infiltrate	1/1000 (0.1%)	1
Mid-Sternal Chest Pressure	3/1000 (0.3%)	3
Multiple Calcified Granulomata in the Lung Fields	1/1000 (0.1%)	1
Obstructive Sleep Apnea	2/1000 (0.2%)	2
Pleural Effusion	6/1000 (0.6%)	7
Pneumonia	4/1000 (0.4%)	5
Pneumothorax	3/1000 (0.3%)	4
Pulmonary Congestion	1/1000 (0.1%)	1
Pulmonary Embolism	4/1000 (0.4%)	4
Pulmonary Hypertension	3/1000 (0.3%)	3
Pulmonary Nodule	1/1000 (0.1%)	1
Pulmonary Venous Congestion	1/1000 (0.1%)	1
Respiratory Illness	1/1000 (0.1%)	1
Tachypnea	1/1000 (0.1%)	1
Skin and subcutaneous tissue disorders
Bacterial Infection of the Skin	2/1000 (0.2%)	2
Dermatitis	1/1000 (0.1%)	1
Drug Rash	2/1000 (0.2%)	3
Head and Neck Abscesses	1/1000 (0.1%)	1
Rash	3/1000 (0.3%)	3
Skin Lesions	1/1000 (0.1%)	1
Surgical and medical procedures
Elective Surgery	3/1000 (0.3%)	3
Vascular disorders
Arterial Hypertension/Hypertension	5/1000 (0.5%)	5
Coronary Artery Anomaly	1/1000 (0.1%)	1
Coronary Artery Disease	2/1000 (0.2%)	2
Deep Vein Thrombosis	2/1000 (0.2%)	2
Dilated Main Pulmonary Artery (MPA)	1/1000 (0.1%)	1
Peripheral Vascular Disease	1/1000 (0.1%)	1
Stroke	1/1000 (0.1%)	1
Transient Ischemic Attack	1/1000 (0.1%)	1
VASC Bleeding	2/1000 (0.2%)	2
VASC Bruise	1/1000 (0.1%)	1
VASC Hematoma	5/1000 (0.5%)	5
VASC Pain	5/1000 (0.5%)	5
VASC Pseudoaneurysm	2/1000 (0.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.