AMPLATZER Cardiac Plug Clinical Trial
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01118299
Collaborator
(none)
97
18
2
103.4
5.4
0.1
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Amplatzer Cardiac Plug Clinical Trial
Actual Study Start Date
:
Apr 26, 2010
Actual Primary Completion Date
:
Dec 6, 2018
Actual Study Completion Date
:
Dec 6, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Device AMPLATZER Cardiac Plug |
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
|
| Active Comparator: Optimal Medical Therapy (control) Warfarin Dabigatran |
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
|
Outcome Measures
Primary Outcome Measures
- Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only [From Randomization to Discharge Visit]
An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.
- Long-term Safety - Device Arm Only [Randomization to 2 year follow-up]
All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
- Effectiveness Endpoint - Device Arm Only [Randomization through 2 year follow up]
Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
-
Subject must be ≥18 years of age
-
Subject must be on warfarin or dabigatran therapy
-
Subject must be eligible for long term warfarin or dabigatran therapy
-
Subject must have a CHADS(2) score of 2 or greater
Summary of Exclusion Criteria:
-
Subject who requires warfarin or dabigatran for a condition other than AF
-
Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
-
Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
-
Subject with a New York Heart Association (NYHA) classification equal to IV
-
Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
-
Subject with aortic or mitral valve regurgitation of grade 2+ or greater
-
Subject with left ventricular ejection fraction (LVEF) ≤30
-
Subject with mitral or aortic prosthetic valve
-
Subject with a history of hemorrhagic or aneurysmal stroke
-
Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
-
Subject with a body mass index (BMI) ≥40
-
Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
-
Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Good Samaritan Hospital | Los Angeles | California | United States | 90017 |
| 2 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 3 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
| 4 | South Denver Cardiology Associates | Littleton | Colorado | United States | 80120 |
| 5 | Emory Midtown Hospital and Emory University Hospital | Atlanta | Georgia | United States | 30308 |
| 6 | St. Joseph's Hospital and Research Institute | Atlanta | Georgia | United States | |
| 7 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
| 8 | University of Kentucky | Lexington | Kentucky | United States | 40506 |
| 9 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 10 | Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 11 | Providence Hospital | Southfield | Michigan | United States | 48075 |
| 12 | St. Cloud Hospital/CentraCare Heart and Vascular Clinic | Saint Cloud | Minnesota | United States | 56303 |
| 13 | HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | United States | 55102 |
| 14 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 15 | York Hospital | York | Pennsylvania | United States | 17405 |
| 16 | Roper Hospital/PMG Research of Charleston | Charleston | South Carolina | United States | 29401 |
| 17 | Memorial Hermann Hospital | Houston | Texas | United States | 77030 |
| 18 | Aspirus Heart & Vascular Institute | Wausau | Wisconsin | United States | 54401 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
- What is Atrial Fibrillation - Fact Sheet
- Overview of Atrial Fibrillation
- Let's Talk about Stroke, TIA and Warning Signs - Fact Sheet
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01118299
Other Study ID Numbers:
- CL00921
First Posted:
May 6, 2010
Last Update Posted:
Apr 14, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Device | Optimal Medical Therapy (Control) |
|---|---|---|
| Arm/Group Description | AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device | Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device |
| Period Title: Overall Study | ||
| STARTED | 68 | 29 |
| COMPLETED | 45 | 0 |
| NOT COMPLETED | 23 | 29 |
Baseline Characteristics
| Arm/Group Title | Device | Optimal Medical Therapy (Control) | Total |
|---|---|---|---|
| Arm/Group Description | AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device | Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device | Total of all reporting groups |
| Overall Participants | 68 | 29 | 97 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
74.0
(8.5)
|
73.4
(10.0)
|
73.5
(8.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
33.8%
|
11
37.9%
|
34
35.1%
|
| Male |
45
66.2%
|
18
62.1%
|
63
64.9%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| CHADS2 Score (Count of Participants) | |||
| Chads2 Score 0 |
0
0%
|
0
0%
|
0
0%
|
| Chads2 Score 1 |
0
0%
|
0
0%
|
0
0%
|
| Chads2 Score 2 |
38
55.9%
|
17
58.6%
|
55
56.7%
|
| Chads2 Score 3 |
20
29.4%
|
7
24.1%
|
27
27.8%
|
| Chads2 Score 4 |
7
10.3%
|
4
13.8%
|
11
11.3%
|
| Chads2 Score 5 |
2
2.9%
|
1
3.4%
|
3
3.1%
|
| Chads2 Score 6 |
1
1.5%
|
0
0%
|
1
1%
|
| History of Atrial Fibrillation (Count of Participants) | |||
| Paroxysmal |
32
47.1%
|
19
65.5%
|
51
52.6%
|
| Persistent |
21
30.9%
|
7
24.1%
|
28
28.9%
|
| Permanent |
15
22.1%
|
3
10.3%
|
18
18.6%
|
| Rhythm Status at Baseline (Count of Participants) | |||
| Paced Rhythm |
17
25%
|
15
51.7%
|
32
33%
|
| Atrial Fibrillation |
29
42.6%
|
5
17.2%
|
34
35.1%
|
| Sinus Rhythm |
19
27.9%
|
7
24.1%
|
26
26.8%
|
| Other Arrhythmias or Conduction Disturbance |
2
2.9%
|
2
6.9%
|
4
4.1%
|
Outcome Measures
| Title | Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only |
|---|---|
| Description | An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol. |
| Time Frame | From Randomization to Discharge Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm. |
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | Subjects who received the ACP device |
| Measure Participants | 68 |
| Device Embolization |
3
|
| Pleural Effusion |
1
|
| Hematoma |
1
|
| Pericardial Tamponade |
3
|
| Cardiac Perforation* |
1
|
| Pericardial Effusion |
1
|
| Cardiogenic Shock* |
1
|
| Pericarditis* |
1
|
| Title | Long-term Safety - Device Arm Only |
|---|---|
| Description | All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
| Time Frame | Randomization to 2 year follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm. |
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | Subjects who received the ACP device |
| Measure Participants | 68 |
| Empyema (Major Bleeding) |
1
|
| Hemothorax (Major Bleeding) |
1
|
| Hematoma (Major Bleeidng) |
1
|
| Bleeding (Major Bleeding) |
1
|
| Respiratory Failure (Death) |
2
|
| Congestive Heart Failure (Death) |
1
|
| Device Embolization (Death) |
1
|
| Title | Effectiveness Endpoint - Device Arm Only |
|---|---|
| Description | Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
| Time Frame | Randomization through 2 year follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm. |
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | Subjects who received the ACP device |
| Measure Participants | 68 |
| Ischemic Stroke |
2
|
| Peripheral Thromboembolism |
0
|
Adverse Events
| Time Frame | 5 Years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders. | |||
| Arm/Group Title | Device | Optimal Medical Therapy (Control) | ||
| Arm/Group Description | AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device | Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device | ||
All Cause Mortality |
||||
| Device | Optimal Medical Therapy (Control) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/68 (10.3%) | 5/29 (17.2%) | ||
Serious Adverse Events |
||||
| Device | Optimal Medical Therapy (Control) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 52/68 (76.5%) | 15/29 (51.7%) | ||
| Cardiac disorders | ||||
| Abnormal Coagulation Parameter | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Abnormal Lab Value | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Acute Bronchitis | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Acute Erosive Gastritis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Acute Pancreatitis | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Acute Renal Failure | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Angina Pectoris | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Arthritis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Atrial Fibrillation | 8/68 (11.8%) | 10 | 1/29 (3.4%) | 1 |
| Atrial Flutter | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Atrial Tachycardia | 0/68 (0%) | 0 | 2/29 (6.9%) | 2 |
| Bacteremia | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Bacterial Infections | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Benign Tumors | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Bleeding | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Breast Cancer | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Cancer | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Cardiac Arrest | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cardiac Perforation* | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cardiogenic Shock* | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cellulitis | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Cerebral Aneurysm | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cervical Stenosis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Chest Pain | 4/68 (5.9%) | 4 | 0/29 (0%) | 0 |
| Cholecystitis | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Chronic Obstructive Pulmonary Disease (COPD) | 2/68 (2.9%) | 6 | 1/29 (3.4%) | 1 |
| Closed Head Injury | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Colitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Confusion | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Congestive Heart Failure | 5/68 (7.4%) | 6 | 6/29 (20.7%) | 7 |
| Constrictive Pericarditis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Coronary Artery Disease | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Deep Vein/Venous Thrombosis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Dehydration | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Delirium | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Device Closure of ASD | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Device Embolization | 4/68 (5.9%) | 4 | 0/29 (0%) | 0 |
| Drug Side Effect | 0/68 (0%) | 0 | 1/29 (3.4%) | 2 |
| Dysphagia | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Dyspnea | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Ear Infection | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Elective Procedure | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Elective Surgery | 1/68 (1.5%) | 1 | 2/29 (6.9%) | 2 |
| Emphysema | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Empyema | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Encephalopathy | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Esophageal Laceration and Rupture | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Fall | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Fracture | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Gout | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Heart Failure | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hemarthrosis | 1/68 (1.5%) | 2 | 0/29 (0%) | 0 |
| Hematoma | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Hemorrhagic Stroke | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hemothorax | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hip Fracture | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Hydrocephalus | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Hypertensive Crisis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hyponatremia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hypotension | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Ischemic Stroke | 2/68 (2.9%) | 2 | 2/29 (6.9%) | 2 |
| Knee Pain | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Low Back Pain | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Lumbar Disc Displacement | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Lumbar Spondylosis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Melena | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Migraine | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Mononucleosis | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Myocardial Infarction | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Osteoarthritis/Degenerative Joint Disease | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Other: Pancreatic pseudocyst | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Paroxysmal Atrial Fibrillation | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Pericardial Effusion | 5/68 (7.4%) | 5 | 0/29 (0%) | 0 |
| Pericardial Tamponade | 4/68 (5.9%) | 4 | 0/29 (0%) | 0 |
| Pericarditis* | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Peripheral Arterial Occlusion | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Persistent Atrial Fibrillation | 3/68 (4.4%) | 6 | 0/29 (0%) | 0 |
| Pleural Effusion | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Pneumonia | 4/68 (5.9%) | 8 | 2/29 (6.9%) | 2 |
| Polyneuropathy | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Presyncope | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pulmonary Embolism | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Renal Failure | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Renal Insufficiency | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Respiratory Failure | 3/68 (4.4%) | 4 | 0/29 (0%) | 0 |
| Sepsis | 3/68 (4.4%) | 5 | 2/29 (6.9%) | 2 |
| Sick Sinus Syndrome | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | 2/68 (2.9%) | 2 | 2/29 (6.9%) | 2 |
| Sinusitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Spells | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Spinal Stenosis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Stroke | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Syncope | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Transient Ischemic Attack (TIA) | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Trauma | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Unstable Angina | 1/68 (1.5%) | 2 | 0/29 (0%) | 0 |
| VASC Bleeding | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| VASC Hematoma | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Vancomycin-Resistant Enterococcus | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Ventricular Tachycardia | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Viral Gastroenteritis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Visual Disturbance | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Device | Optimal Medical Therapy (Control) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/68 (89.7%) | 15/29 (51.7%) | ||
| Cardiac disorders | ||||
| Abdominal Bloating | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Abdominal Pain | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Abnormal Coagulation Parameter | 1/68 (1.5%) | 2 | 1/29 (3.4%) | 1 |
| Abnormal Lab Value | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Abnormal Renal Function | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Abrasion | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Acute Bronchitis | 4/68 (5.9%) | 4 | 1/29 (3.4%) | 1 |
| Acute Kidney Injury | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Acute Renal Failure | 0/68 (0%) | 0 | 2/29 (6.9%) | 2 |
| Air Embolus | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Allergic Drug Reaction | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Allergy | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Anemias | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Animal Bite | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Anxiety | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Anxiety Reaction | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Aortic Aneurysms | 0/68 (0%) | 0 | 2/29 (6.9%) | 2 |
| Aortic Valve Stranding | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Aphasia | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Arm Fracture | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Arterial Hypertension/Hypertension | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Arthritis | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Asthma | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Asymptomatic Ischemic Stroke | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Atelectasis | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Atrial Fibrillation | 6/68 (8.8%) | 9 | 1/29 (3.4%) | 1 |
| Atrial Flutter | 0/68 (0%) | 0 | 2/29 (6.9%) | 2 |
| Back Pain | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Bee Sting | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Behavior Alterations | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Bells Palsy | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Bleeding | 5/68 (7.4%) | 5 | 0/29 (0%) | 0 |
| Bronchitis | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Bruise/Purpura Simplex | 5/68 (7.4%) | 6 | 1/29 (3.4%) | 1 |
| Bursitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Carpal Tunnel | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cataract | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Cellulitis | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Chest Pain | 3/68 (4.4%) | 3 | 2/29 (6.9%) | 3 |
| Chronic Obstructive Pulmonary Disease (COPD) | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Chronic Renal Failure | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Chronic Subdural Hematoma | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Colitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Colon Polyps | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Common Cold/Upper Respiratory Tract Infection | 4/68 (5.9%) | 4 | 0/29 (0%) | 0 |
| Compressive Effect On Nerve | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Concussion | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Congestive Heart Failure | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Constipation | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Contusion | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Cough | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Decreased Appetite | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Decreased Sphincter Tone | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Dehydration | 1/68 (1.5%) | 2 | 0/29 (0%) | 0 |
| Depression | 3/68 (4.4%) | 3 | 1/29 (3.4%) | 1 |
| Device Malposition or Malfunction | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Diarrhea | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Diastolic Dysfunction | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Difficulty Catching Breath | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Diplopia/Double Vision | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Diverticulitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Dizziness | 3/68 (4.4%) | 4 | 0/29 (0%) | 0 |
| Drug Rash | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Drug Side Effect | 2/68 (2.9%) | 3 | 1/29 (3.4%) | 1 |
| Dyspepsia | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Dysphagia | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Dyspnea | 7/68 (10.3%) | 7 | 1/29 (3.4%) | 1 |
| Earache | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Edema | 9/68 (13.2%) | 9 | 2/29 (6.9%) | 2 |
| Elective Procedure | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Elective Surgery | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Emesis/Vomiting | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Encephalopathy | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Epididymitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Epistaxis | 2/68 (2.9%) | 2 | 2/29 (6.9%) | 2 |
| Erectile Dysfunction Symptoms | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Eye Swelling | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Fall | 6/68 (8.8%) | 7 | 2/29 (6.9%) | 2 |
| Fatigue/Generalized Fatigue | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| Fever | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Folliculitis | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Fracture | 2/68 (2.9%) | 2 | 1/29 (3.4%) | 1 |
| Fungal Skin Infection | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Gastritis | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Gastrointestinal Bleeding | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Gastrointestinal Illness | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Gingival Bleeding | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Gout | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Headache | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Heart Failure | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Heartburn | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Hemarthrosis | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Hematoma | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Hematuria | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Hemoptysis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hepatic and Biliary Disorders | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hip Pain | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Hyperkalemia | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Hypernatremia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hypokalemia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Hypotension | 8/68 (11.8%) | 8 | 0/29 (0%) | 0 |
| Hypoxemia | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Incidental Finding of Stroke | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Intracerebral Haemorrhage | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Iron-Deficiency Anemia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Junctional Escape Rhythm/Intermittent Junctional Rhythm | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Knee Pain | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Lacerations | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Lightheadedness | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Low Back Pain | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Lung Crackles | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Memory Difficulty | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Microhemorrhage | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Mitral Valve Regurgitation/Mitral Insufficiency | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Musculoskeletal Pain | 1/68 (1.5%) | 1 | 2/29 (6.9%) | 2 |
| Nausea | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Neck Pain | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Nephrolithiasis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Nocturia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Non-Specific EKG Change | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Numbness | 5/68 (7.4%) | 5 | 0/29 (0%) | 0 |
| Onychomycosis | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Overhydration | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pain | 3/68 (4.4%) | 4 | 1/29 (3.4%) | 1 |
| Palpitations | 5/68 (7.4%) | 5 | 2/29 (6.9%) | 2 |
| Parkinson's Disease | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Paroxysmal Atrial Fibrillation | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Pericardial Effusion | 5/68 (7.4%) | 5 | 0/29 (0%) | 0 |
| Peripheral Venous Thrombus | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Persistent Atrial Fibrillation | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Phlebitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Plantar Fasciitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pleural Effusion | 2/68 (2.9%) | 4 | 1/29 (3.4%) | 1 |
| Pleuretic Pain | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pneumonia | 3/68 (4.4%) | 4 | 3/29 (10.3%) | 3 |
| Pneumothorax | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Post-Menopausal Bleeding | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pressure Sores | 0/68 (0%) | 0 | 2/29 (6.9%) | 2 |
| Psychogenic Event | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Pulmonary Hypertension | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Ramsay Hunt Syndrome | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Rash | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Residual Interatrial Communication | 7/68 (10.3%) | 7 | 0/29 (0%) | 0 |
| Respiratory Illness | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Rhinitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| ST Segment Changes | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Sciatica | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Shingles | 4/68 (5.9%) | 4 | 0/29 (0%) | 0 |
| Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Sinusitis | 2/68 (2.9%) | 3 | 0/29 (0%) | 0 |
| Skin Cancer | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Skin Lesions | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Skin Ulcer | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Sore Throat | 5/68 (7.4%) | 6 | 0/29 (0%) | 0 |
| Spells | 1/68 (1.5%) | 3 | 2/29 (6.9%) | 2 |
| Stupor | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Syncope | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Tachycardia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Temporomandibular Joint | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Tendosynovitis | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Thrombocytopenia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Thrombus on Device | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Thyroid Disorders | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Toe Inflammation | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Transient Imbalance | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Transient Ischemic Attack (TIA) | 0/68 (0%) | 0 | 1/29 (3.4%) | 2 |
| Trauma | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Tremor | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Uncontrolled Blood Sugar | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Urinary Incontinence | 0/68 (0%) | 0 | 1/29 (3.4%) | 1 |
| Urinary Retention | 3/68 (4.4%) | 3 | 1/29 (3.4%) | 1 |
| Urinary Tract Infections | 6/68 (8.8%) | 7 | 1/29 (3.4%) | 1 |
| VASC Bleeding | 10/68 (14.7%) | 10 | 0/29 (0%) | 0 |
| VASC Bruise | 3/68 (4.4%) | 3 | 0/29 (0%) | 0 |
| VASC Hematoma | 7/68 (10.3%) | 7 | 0/29 (0%) | 0 |
| VASC Pseudoaneurysm | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
| Ventricular Tachycardia | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Vertigo | 2/68 (2.9%) | 2 | 0/29 (0%) | 0 |
| Visual Disturbance | 1/68 (1.5%) | 1 | 1/29 (3.4%) | 1 |
| Weakness | 1/68 (1.5%) | 1 | 0/29 (0%) | 0 |
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 | Sripad Bellary |
|---|---|
| Organization | Abbott |
| Phone | 408845814 |
| sripad.bellary@abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01118299
Other Study ID Numbers:
- CL00921
First Posted:
May 6, 2010
Last Update Posted:
Apr 14, 2020
Last Verified:
Apr 1, 2020