Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00465270
Collaborator
(none)
980
69
2
153
14.2
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
Study Design
Study Type:
Interventional
Actual Enrollment
:
980 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
AMPLATZER PFO OccluderAMPLATZER PFO Occluder
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
Actual Study Start Date
:
Aug 1, 2003
Actual Primary Completion Date
:
May 1, 2012
Actual Study Completion Date
:
May 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Device AMPLATZER PFO Occluder |
Device: AMPLATZER PFO Occluder
patent foramen ovale closure device
|
| Active Comparator: Standard or Care - Medical Management Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. |
Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
|
Outcome Measures
Primary Outcome Measures
- Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization [Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.]
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
Secondary Outcome Measures
- Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who have had a cryptogenic stroke within the last 270 days
-
Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
-
Subjects willing to participate in follow-up visits
Exclusion Criteria:
-
Subjects with intracardiac thrombus or tumor
-
Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
-
Subjects with left ventricular aneurysm or akinesis
-
Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
-
Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
-
Subjects with contraindication to aspirin or Clopidogrel therapy
-
Pregnant or desire to become pregnant within the next year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama | Birmingham | Alabama | United States | 35249 |
| 2 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
| 3 | LAC + USC Medical Center | Los Angeles | California | United States | 90033 |
| 4 | UCLA | Los Angeles | California | United States | 90095 |
| 5 | Summit Medical Center | Oakland | California | United States | 94609 |
| 6 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
| 7 | Kaiser Permanente | San Francisco | California | United States | 94115 |
| 8 | University of Colorado | Denver | Colorado | United States | 80262 |
| 9 | South Denver Cardiology Associates | Littleton | Colorado | United States | 80120 |
| 10 | Medical Center of the Rockies | Loveland | Colorado | United States | 80538 |
| 11 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 12 | George Washington University Hospital | Washington | District of Columbia | United States | 20037 |
| 13 | St. Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
| 14 | Northwestern University | Chicago | Illinois | United States | 60611-3078 |
| 15 | University of Chicago | Chicago | Illinois | United States | 60637-1470 |
| 16 | Neurologic Associates Inc | Palos Heights | Illinois | United States | 60463 |
| 17 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 18 | Southern Illinois University Neurology | Springfield | Illinois | United States | 62702 |
| 19 | Indiana Heart Physicians | Indianapolis | Indiana | United States | 46237 |
| 20 | Ruan Neurology | Des Moines | Iowa | United States | 50314 |
| 21 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 22 | Kansas University Medical Center | Kansas City | Kansas | United States | 66160 |
| 23 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 24 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 25 | Midatlantic Cardiovascular Associates | Towson | Maryland | United States | 21014 |
| 26 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 27 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109-0316 |
| 28 | St. Mary's Duluth Clinic | Duluth | Minnesota | United States | 55805 |
| 29 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 30 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 31 | Methodist Hospital/Park Nicollet Medical Center | Saint Louis Park | Minnesota | United States | 55426 |
| 32 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 33 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-2045 |
| 34 | Our Lady of Lourdes Medical Center | Cherry Hill | New Jersey | United States | 08034 |
| 35 | University of Medicine and Dentistry of New Jersy | Newark | New Jersey | United States | 07103 |
| 36 | Albany Medical Center | Albany | New York | United States | 12208 |
| 37 | DENT Neurologic Institute | Amherst | New York | United States | 14226 |
| 38 | University of Rochester | Rochester | New York | United States | 14642 |
| 39 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 40 | Moses H. Cone Memorial Hospital | Greensboro | North Carolina | United States | 27410 |
| 41 | Neurology and Neuroscience Associates | Akron | Ohio | United States | 44320 |
| 42 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 43 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 44 | Providence St. Vincent's Medical Center | Portland | Oregon | United States | 97225 |
| 45 | Oregon Stroke Center, OHSU | Portland | Oregon | United States | 97329 |
| 46 | LeHigh Valley Hospital | Allentown | Pennsylvania | United States | 18105 |
| 47 | Penn State Milton South Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 48 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17543 |
| 49 | St. Mary's Medical Center | Langhorne | Pennsylvania | United States | 19067 |
| 50 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 51 | North Central Heart Institute | Sioux Falls | South Dakota | United States | 57108 |
| 52 | St. Thomas Neurology | Nashville | Tennessee | United States | 37205 |
| 53 | Vanderbilt University | Nashville | Tennessee | United States | 37232-8802 |
| 54 | UT Southwestern Medical School | Dallas | Texas | United States | 75390-8897 |
| 55 | University of Texas Houston Health Science Center | Houston | Texas | United States | 77030 |
| 56 | Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | United States | 23454 |
| 57 | UW Medicine Stroke Center | Seattle | Washington | United States | 98104 |
| 58 | Charleston Area Medical Center | Charleston | West Virginia | United States | 25304 |
| 59 | University of Wisconsin Hospital | Madison | Wisconsin | United States | 53792 |
| 60 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 61 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 62 | University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
| 63 | University of Alberta | Edmonton | Alberta | Canada | T6G 2B7 |
| 64 | Royal Columbian Hospital | New Westminster | British Columbia | Canada | V3L 3W5 |
| 65 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 66 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V5Z 1Y6 |
| 67 | Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute | London | Ontario | Canada | N6G 2V2 |
| 68 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 69 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T 1C8 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Jeffrey Saver, MD, UCLA Stroke Center
- Principal Investigator: John D Carroll, MD, University of Colorado, Denver
- Principal Investigator: Richard Smalling, MD, University of Texas Houston Health Science Center
- Principal Investigator: David Thaler, MD, Tufts Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.
- Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00465270
Other Study ID Numbers:
- AGA-006
- G990318
First Posted:
Apr 24, 2007
Last Update Posted:
Feb 18, 2019
Last Verified:
Jan 1, 2019
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Device | Medical Management |
|---|---|---|
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device | Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. |
| Period Title: Overall Study | ||
| STARTED | 499 | 481 |
| COMPLETED | 395 | 321 |
| NOT COMPLETED | 104 | 160 |
Baseline Characteristics
| Arm/Group Title | Device | Medical Management | Total |
|---|---|---|---|
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device | Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole | Total of all reporting groups |
| Overall Participants | 499 | 481 | 980 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45.7
(9.7)
|
46.2
(10.0)
|
45.9
(9.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
231
46.3%
|
213
44.3%
|
444
45.3%
|
| Male |
268
53.7%
|
268
55.7%
|
536
54.7%
|
Outcome Measures
| Title | Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization |
|---|---|
| Description | Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last. |
| Time Frame | Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All primary endpoints that occurred in the trial were recurrent non-fatal ischemic strokes. |
| Arm/Group Title | Device | Medical Management |
|---|---|---|
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device | Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole |
| Measure Participants | 499 | 481 |
| Count of Participants [Participants] |
9
1.8%
|
16
3.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Device, Medical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.49 | |
| Confidence Interval |
(2-Sided) 95% 0.22 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group |
|---|---|
| Description | |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only subjects with complete PFO closure data at 6-months were analyzed. |
| Arm/Group Title | Device |
|---|---|
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device |
| Measure Participants | 349 |
| Count of Participants [Participants] |
249
49.9%
|
| Title | Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up |
|---|---|
| Description | |
| Time Frame | Long Term Follow-up, median of 5.9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Device | Medical Management |
|---|---|---|
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device | Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole |
| Measure Participants | 499 | 481 |
| Count of Participants [Participants] |
18
3.6%
|
28
5.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Device, Medical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.55 | |
| Confidence Interval |
(2-Sided) 95% 0.31 to 0.999 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Device | Medical Management | ||
| Arm/Group Description | AMPLATZER PFO Occluder: patent foramen ovale closure device | Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole | ||
All Cause Mortality |
||||
| Device | Medical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/499 (1.4%) | 11/481 (2.3%) | ||
Serious Adverse Events |
||||
| Device | Medical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 201/499 (40.3%) | 173/481 (36%) | ||
| General disorders | ||||
| ASD | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Abdominal Pain | 2/499 (0.4%) | 2 | 2/481 (0.4%) | 3 |
| Abnormal Lab Value | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Acute Bacterial Endocarditis (ABE) | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Acute Bronchitis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Acute Erosive Gastritis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Acute Gastroenteritis | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Acute Pancreatitis | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Acute Peritonitis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Acute Pulmonary Edema | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Acute Renal Failure | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Acute Subdural Hematoma | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Alcohol Intoxication | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Allergic Device Reaction | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Allergic Drug Reaction | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Altered Sensorium | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Anemias | 4/499 (0.8%) | 4 | 0/481 (0%) | 0 |
| Angina Pectoris | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Ankle Fracture | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Anterior Meniscus Tear | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Anxiety | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Aortic Aneurysms | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Appendicitis | 4/499 (0.8%) | 4 | 2/481 (0.4%) | 2 |
| Arm Fracture | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Arterial Hypertension/Hypertension | 4/499 (0.8%) | 4 | 1/481 (0.2%) | 1 |
| Arthritis | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Asthma | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Atrial Fibrillation | 6/499 (1.2%) | 8 | 4/481 (0.8%) | 4 |
| Atrial Flutter | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Back Pain | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Bacterial Infections | 0/499 (0%) | 0 | 3/481 (0.6%) | 3 |
| Bacterial Infections of the Skin | 2/499 (0.4%) | 3 | 1/481 (0.2%) | 1 |
| Benign Mass | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Bipolar Disorder | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Birth Defect | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Bleeding | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Blood Loss | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Bowel Obstruction | 4/499 (0.8%) | 5 | 2/481 (0.4%) | 2 |
| Brain Abcess | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Brain Tumor | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Breast Cancer | 6/499 (1.2%) | 6 | 2/481 (0.4%) | 2 |
| Bronchiolitis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Bronchitis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Burns | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Caesarean Section | 5/499 (1%) | 5 | 3/481 (0.6%) | 4 |
| Cancer | 5/499 (1%) | 6 | 7/481 (1.5%) | 7 |
| Cardiac Arrest | 1/499 (0.2%) | 1 | 3/481 (0.6%) | 3 |
| Cardiac Perforation | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cardiac Thrombus | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Cardiomyopathy | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cellulitis | 2/499 (0.4%) | 3 | 6/481 (1.2%) | 6 |
| Cerebral Aneurysm | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Cerebral Infarct - Asymptomatic*** | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Cerebrospinal Fluid (CSF) Leak | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Cervical Spondylosis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cervical Stenosis | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Chest Pain | 18/499 (3.6%) | 19 | 15/481 (3.1%) | 16 |
| Chest Tightness | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Chills/Rigors | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cholecystitis | 1/499 (0.2%) | 1 | 5/481 (1%) | 5 |
| Choledochal Cysts | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Choledocholithiaisis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cholelithiasis | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Chronic Obstructive Airway Disorders | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Chronic Obstructive Pulmonary Disease (COPD) | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Chronic Pancreatitis | 1/499 (0.2%) | 2 | 0/481 (0%) | 0 |
| Closed Head Injury | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Colitis | 3/499 (0.6%) | 3 | 2/481 (0.4%) | 2 |
| Colon Cancer | 1/499 (0.2%) | 3 | 1/481 (0.2%) | 1 |
| Common Cold/Upper Respiratory Tract Infection | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Compartment Syndrome | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Complex Partial Seizures | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Confusion | 0/499 (0%) | 0 | 2/481 (0.4%) | 3 |
| Congestive Heart Failure | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Conversion Reaction | 2/499 (0.4%) | 3 | 0/481 (0%) | 0 |
| Coronary Artery Disease | 3/499 (0.6%) | 3 | 2/481 (0.4%) | 2 |
| Cutaneous Abcesses | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Deep Vein/Venous Thrombosis | 5/499 (1%) | 5 | 1/481 (0.2%) | 1 |
| Dehydration | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Delirium | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Depression | 2/499 (0.4%) | 3 | 4/481 (0.8%) | 5 |
| Disc Protrusion | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Diverticulitis | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Dizziness | 2/499 (0.4%) | 3 | 2/481 (0.4%) | 2 |
| Drug Side Effect | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Duodenal Cancer | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Dysarthria/Slurred Speech | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Dyspnea | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Elective Surgery | 26/499 (5.2%) | 32 | 17/481 (3.5%) | 20 |
| Emesis/Vomiting | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Encephalopathy | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Eye Lacerations | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Failure to Thrive | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Fall | 3/499 (0.6%) | 3 | 2/481 (0.4%) | 2 |
| Fenestrated Atrial Septum | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Fever | 1/499 (0.2%) | 2 | 0/481 (0%) | 0 |
| Fracture | 3/499 (0.6%) | 4 | 0/481 (0%) | 0 |
| Gastritis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Gastroenteritis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Gastroesophageal Reflux Disease | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Gastrointestinal Bleeding | 6/499 (1.2%) | 6 | 4/481 (0.8%) | 4 |
| Generalized Seizures | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Generalized Tonic-Clonic Seizures | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Headache | 4/499 (0.8%) | 4 | 1/481 (0.2%) | 1 |
| Hematoma | 1/499 (0.2%) | 2 | 2/481 (0.4%) | 2 |
| Hemiparesis/Weakness | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Hemorrhagic Stroke | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Hepatic and Biliary Disorders | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Hernia | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Herniated Disc | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Hip Dislocation | 0/499 (0%) | 0 | 1/481 (0.2%) | 2 |
| Hip Fracture | 1/499 (0.2%) | 1 | 3/481 (0.6%) | 3 |
| Hip Pain | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Homicide | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Hydrocephalus | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Hypercarbia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Hypertensive Encephalopathy | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Hypoglycemia | 1/499 (0.2%) | 2 | 0/481 (0%) | 0 |
| Hyponatremia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Hysterectomy | 5/499 (1%) | 5 | 4/481 (0.8%) | 4 |
| Infective/Bacterial Endocarditis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Inferior Myocardial Infarction | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Inguinal Hernia | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Intracerebral Haemorrhage | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Intraparenchymal Haemorrhage | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Ischemic Eighth Nerve | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Ischemic Stroke | 18/499 (3.6%) | 19 | 28/481 (5.8%) | 31 |
| Knee Pain | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Lacerations | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Leukemias | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Long Q-T | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Low Back Pain | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Lung Cancer | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Melanoma | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Melena | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Menorrhagia | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Microcytic Anemia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Migraine | 12/499 (2.4%) | 15 | 7/481 (1.5%) | 9 |
| Missed Abortion | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Multiple Sclerosis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Musculoskeletal Pain | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Myocardial Infarction | 6/499 (1.2%) | 6 | 1/481 (0.2%) | 1 |
| Nausea | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Neck Pain | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Non-Endpoint Transient Ischemic Attack (TIA) | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Numbness | 3/499 (0.6%) | 3 | 4/481 (0.8%) | 4 |
| Obesity | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Orthostatic Hypotension | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Osler Weber Rendu Syndrome | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Osteoarthritis/Degenerative Joint Disease | 3/499 (0.6%) | 4 | 6/481 (1.2%) | 7 |
| Other - Preterm labor | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Other - SIRS | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Other - Splenic infarcts | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Overdose | 4/499 (0.8%) | 7 | 3/481 (0.6%) | 5 |
| Pain | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Palpitations | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Pancreatic Cancer | 0/499 (0%) | 0 | 2/481 (0.4%) | 3 |
| Panic Attack | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Paresthesia/Paraesthesia | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Pericardial Effusion | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Pericardial Tamponade | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Pericarditis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Peripheral Arterial Occlusion | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Peripheral Venous Thrombus | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Pleurisy | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Pneumonia | 5/499 (1%) | 9 | 6/481 (1.2%) | 6 |
| Pneumonia Caused By Haemophilus Influenzae | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Pneumothorax | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Possible Seizure | 2/499 (0.4%) | 2 | 2/481 (0.4%) | 2 |
| Pre-eclampsia | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Pregnancy | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Pregnancy Related Symptoms | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Premature Ventricular Contraction | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Presyncope | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Prostate Discomfort | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Pulmonary AVM | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Pulmonary Congestion | 1/499 (0.2%) | 2 | 0/481 (0%) | 0 |
| Pulmonary Embolism | 12/499 (2.4%) | 13 | 3/481 (0.6%) | 3 |
| Radiculopathy | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Residual Shunt Requiring Closure | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Respiratory Illness | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Rhabdomyolysis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Right Hepatic Trocar Injury | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Rotator Cuff Tear | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Seizure Disorder | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Seizure/Convulsions/Epilepsy | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Sepsis | 4/499 (0.8%) | 8 | 3/481 (0.6%) | 5 |
| Simple Partial Seizures | 0/499 (0%) | 0 | 1/481 (0.2%) | 2 |
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Spells | 2/499 (0.4%) | 2 | 3/481 (0.6%) | 3 |
| Spinal Stenosis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Spontaneous Abortion | 3/499 (0.6%) | 4 | 1/481 (0.2%) | 1 |
| Subarachnoid Haemorrhage | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Subdural Haemorrhage | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Suicide Attempt | 4/499 (0.8%) | 4 | 1/481 (0.2%) | 1 |
| Swelling | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Syncope | 3/499 (0.6%) | 3 | 5/481 (1%) | 5 |
| TEE-Related Event | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Thyroid Cancer | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Thyroid Disorders | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Thyrotoxicosis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Tingling | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Transient Global Amnesia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Transient Ischemic Attack (TIA) | 8/499 (1.6%) | 8 | 11/481 (2.3%) | 14 |
| Trauma | 4/499 (0.8%) | 4 | 3/481 (0.6%) | 3 |
| Tubal Ligation | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Uncontrolled Blood Sugar | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Unmasking Old Stroke Symptoms | 3/499 (0.6%) | 3 | 2/481 (0.4%) | 2 |
| Unstable Angina | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Urinary Calculi | 2/499 (0.4%) | 2 | 2/481 (0.4%) | 2 |
| Urinary Incontinence | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Urinary Tract Infections | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Uterine Fibroid | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Uterine Prolapse | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| VASC Bleeding | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| VASC Hematoma | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Vaginal Child Birth | 10/499 (2%) | 10 | 5/481 (1%) | 7 |
| Vaso Vagal Response | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Vertigo | 5/499 (1%) | 5 | 2/481 (0.4%) | 2 |
| Viral Gastroenteritis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Weakness | 1/499 (0.2%) | 2 | 0/481 (0%) | 0 |
| Worsening Vision | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Wound Infection | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Device | Medical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 285/499 (57.1%) | 70/481 (14.6%) | ||
| General disorders | ||||
| Abdominal Pain | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Abnormal Coagulation Parameter | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Abnormal Lab Value | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Acute Erosive Gastritis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Acute Pulmonary Edema | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Allergic Drug Reaction | 7/499 (1.4%) | 7 | 1/481 (0.2%) | 1 |
| Allergic Dye Reaction | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Anxiety | 2/499 (0.4%) | 2 | 1/481 (0.2%) | 1 |
| Asthma | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Atelectasis | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm | 10/499 (2%) | 10 | 0/481 (0%) | 0 |
| Atrial Fibrillation | 7/499 (1.4%) | 7 | 0/481 (0%) | 0 |
| Atrial Flutter | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Atrial Tachycardia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Back Pain | 5/499 (1%) | 5 | 0/481 (0%) | 0 |
| Bleeding | 4/499 (0.8%) | 5 | 8/481 (1.7%) | 8 |
| Borderline Prolongation of QT Interval | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Bruise/Purpura Simplex | 46/499 (9.2%) | 49 | 26/481 (5.4%) | 28 |
| Buzzing In Chest | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Calf Pain | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cardiac Thrombus | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Cellulitis | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Chest Pain | 47/499 (9.4%) | 48 | 1/481 (0.2%) | 1 |
| Chest Tightness | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Chronic Obstructive Pulmonary Disease (COPD) | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Contact Dermatitis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Cough | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Couplet | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Deep Vein/Venous Thrombosis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Dental Trauma | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Device Malposition or Malfunction | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Diarrhea | 1/499 (0.2%) | 1 | 3/481 (0.6%) | 3 |
| Difficulty Catching Breath | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Dizziness | 4/499 (0.8%) | 4 | 0/481 (0%) | 0 |
| Drug Rash | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Drug Side Effect | 4/499 (0.8%) | 4 | 5/481 (1%) | 5 |
| Dyspepsia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Dyspnea | 7/499 (1.4%) | 7 | 0/481 (0%) | 0 |
| Emesis/Vomiting | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Epistaxis | 7/499 (1.4%) | 7 | 6/481 (1.2%) | 6 |
| Esophagitis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Fainting/Blackout | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Flushing | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Gastritis | 3/499 (0.6%) | 3 | 2/481 (0.4%) | 2 |
| Gastroenteritis | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Gastroesophageal Reflux Disease | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Gastrointestinal Bleeding | 1/499 (0.2%) | 1 | 2/481 (0.4%) | 2 |
| Gastrointestinal Illness | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Gingival Bleeding | 1/499 (0.2%) | 1 | 1/481 (0.2%) | 1 |
| Headache | 8/499 (1.6%) | 8 | 8/481 (1.7%) | 8 |
| Heartburn | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Heaviness of Legs | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Hematochezia | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Hematoma | 4/499 (0.8%) | 4 | 2/481 (0.4%) | 2 |
| Hematuria | 0/499 (0%) | 0 | 2/481 (0.4%) | 2 |
| Hemoptysis | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Hypotension | 5/499 (1%) | 5 | 0/481 (0%) | 0 |
| Hypoxemia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Incomplete Right Bundle Branch Block | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Increased Shunt | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Instillation Site Foreign Body Sensation | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Leg Cramps | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Low Back Pain | 5/499 (1%) | 5 | 0/481 (0%) | 0 |
| Low Hematocrit | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Menorrhagia | 2/499 (0.4%) | 2 | 5/481 (1%) | 5 |
| Meralgia Paraesthetica | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Mid-Sternal Chest Pressure | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Migraine | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Musculoskeletal Pain | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Nausea | 11/499 (2.2%) | 11 | 0/481 (0%) | 0 |
| Non-Specific EKG Change | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Pain | 5/499 (1%) | 5 | 0/481 (0%) | 0 |
| Pain Due to a Catheter Drainage Tube | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Palpitations | 42/499 (8.4%) | 44 | 0/481 (0%) | 0 |
| Paresthesia/Paraesthesia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Paroxysmal Atrial Fibrillation | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Paroxysmal Supraventricular Tachycardia | 4/499 (0.8%) | 4 | 0/481 (0%) | 0 |
| Peptic Ulcer Disease | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Pinching Sensation in Chest | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| Pleural Effusion | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Post-Menopausal Bleeding | 0/499 (0%) | 0 | 1/481 (0.2%) | 1 |
| Presyncope | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Pruritus/Itching | 3/499 (0.6%) | 3 | 1/481 (0.2%) | 1 |
| Pulmonary Congestion | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Right Axis Deviation | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Right Bundle Branch Block/Complete Right Bundle Branch Block | 2/499 (0.4%) | 2 | 0/481 (0%) | 0 |
| ST Segment Changes | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| ST-T Wave Abnormality | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| Sick Sinus Syndrome | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | 19/499 (3.8%) | 20 | 0/481 (0%) | 0 |
| Sinus Tachycardia | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Sore Throat | 3/499 (0.6%) | 3 | 0/481 (0%) | 0 |
| T-Wave Abnormalities | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| TEE-Related Event | 10/499 (2%) | 10 | 1/481 (0.2%) | 1 |
| Trigeminy | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia | 4/499 (0.8%) | 4 | 0/481 (0%) | 0 |
| VASC Bleeding | 16/499 (3.2%) | 16 | 0/481 (0%) | 0 |
| VASC Bruise | 1/499 (0.2%) | 1 | 0/481 (0%) | 0 |
| VASC Hematoma | 36/499 (7.2%) | 36 | 1/481 (0.2%) | 1 |
| VASC Pain | 32/499 (6.4%) | 32 | 0/481 (0%) | 0 |
| Vaso Vagal Response | 6/499 (1.2%) | 6 | 1/481 (0.2%) | 1 |
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.
Results Point of Contact
| Name/Title | Dr. Laura O'Brien |
|---|---|
| Organization | Abbott |
| Phone | |
| laura.obrien@abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00465270
Other Study ID Numbers:
- AGA-006
- G990318
First Posted:
Apr 24, 2007
Last Update Posted:
Feb 18, 2019
Last Verified:
Jan 1, 2019