Trial Outcomes & Findings for Amplatzer™Amulet™ Post-Market Study (Amulet™PMS) (NCT NCT02447081)
NCT ID: NCT02447081
Last Updated: 2019-12-30
Results Overview
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Recruitment status
COMPLETED
Target enrollment
1088 participants
Primary outcome timeframe
0 to 7 days post procedure
Results posted on
2019-12-30
Participant Flow
A total of 1088 subjects were enrolled and attempted implant with Amulet left atrial appendage occluder conducted at 61 sites between June 01, 2015 and September 19, 2016. The final study visit at 2 years post-implant was completed by 864 subjects, with the last study visit occurring in October 2018.
Participant milestones
| Measure |
Subjects Implanted With Amulet Device
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Overall Study
STARTED
|
1088
|
|
Overall Study
COMPLETED
|
864
|
|
Overall Study
NOT COMPLETED
|
224
|
Reasons for withdrawal
| Measure |
Subjects Implanted With Amulet Device
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Overall Study
Death
|
161
|
|
Overall Study
Lost to Follow-up
|
36
|
|
Overall Study
Visit not completed
|
17
|
|
Overall Study
unsuccessful implant procedure
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1088 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=1088 Participants
|
|
Age, Categorical
>=65 years
|
966 Participants
n=1088 Participants
|
|
Age, Continuous
|
75.2 years
STANDARD_DEVIATION 8.5 • n=1088 Participants
|
|
Sex: Female, Male
Female
|
386 Participants
n=1088 Participants
|
|
Sex: Female, Male
Male
|
702 Participants
n=1088 Participants
|
|
Region of Enrollment
United Kingdom
|
59 participants
n=1088 Participants
|
|
Region of Enrollment
Spain
|
105 participants
n=1088 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=1088 Participants
|
|
Region of Enrollment
Sweden
|
13 participants
n=1088 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=1088 Participants
|
|
Region of Enrollment
Norway
|
5 participants
n=1088 Participants
|
|
Region of Enrollment
Finland
|
55 participants
n=1088 Participants
|
|
Region of Enrollment
Poland
|
26 participants
n=1088 Participants
|
|
Region of Enrollment
Denmark
|
62 participants
n=1088 Participants
|
|
Region of Enrollment
Italy
|
178 participants
n=1088 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=1088 Participants
|
|
Region of Enrollment
Australia
|
70 participants
n=1088 Participants
|
|
Region of Enrollment
France
|
65 participants
n=1088 Participants
|
|
Region of Enrollment
Chile
|
6 participants
n=1088 Participants
|
|
Region of Enrollment
Germany
|
378 participants
n=1088 Participants
|
|
Region of Enrollment
Hong Kong
|
41 participants
n=1088 Participants
|
|
Region of Enrollment
Switzerland
|
6 participants
n=1088 Participants
|
PRIMARY outcome
Timeframe: 0 to 7 days post procedureAcute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Acute Serious Adverse Events
|
83 Participants
|
PRIMARY outcome
Timeframe: 7 days through 2 yearsLate adverse events were defined as those serious events with an onset date \> 7 days post-procedure
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
|
504 Participants
|
PRIMARY outcome
Timeframe: Implant through 2 yearsOccurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
|
122 Participants
|
PRIMARY outcome
Timeframe: Implant through 2 yearsClinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Major Bleeding Events
|
110 Participants
|
SECONDARY outcome
Timeframe: During implant procedure, approximately 30 to 60 minutesTechnical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Technical Success
|
1078 Participants
|
SECONDARY outcome
Timeframe: During the implant procedure and hospital stay, approximately 1 or 2 daysProcedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1088 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Procedural Success
|
1039 Participants
|
SECONDARY outcome
Timeframe: At discharge, approximately 1 or 2 days after the procedurePopulation: The number of participates completing a study visit at the Time Frame
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1074 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Oral Anti-coagulation Usage
OAC without anti-platelet therapy
|
49 Participants
|
|
Number of Participants With Oral Anti-coagulation Usage
OAC with antiplatelet therapy
|
71 Participants
|
SECONDARY outcome
Timeframe: At 1 to 3 monthsPopulation: The number of participates completing a study visit at the Time Frame
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1018 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Oral Anti-coagulation Usage
OAC with anti-platelet therapy
|
34 Participants
|
|
Number of Participants With Oral Anti-coagulation Usage
OAC without anti-platelet therapy
|
29 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: The number of participates completing a study visit at the Time Frame
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=1009 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Oral Anti-coagulation Usage
OAC without anti-platelet therapy
|
33 Participants
|
|
Number of Participants With Oral Anti-coagulation Usage
OAC with anti-platelet therapy
|
23 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The number of participates completing a study visit at the Time Frame
Outcome measures
| Measure |
Subjects Implanted With Amulet Device
n=950 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Oral Anti-coagulation Usage
OAC without anti-platelet therapy
|
35 Participants
|
|
Number of Participants With Oral Anti-coagulation Usage
OAC with anti-platelet therapy
|
21 Participants
|
SECONDARY outcome
Timeframe: At 24 monthsOutcome measures
| Measure |
Subjects Implanted With Amulet Device
n=864 Participants
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Number of Participants With Oral Anti-coagulation Usage
OAC without anti-platelet therapy
|
38 Participants
|
|
Number of Participants With Oral Anti-coagulation Usage
OAC with anti-platelet therapy
|
19 Participants
|
Adverse Events
Subjects Implanted With Amulet Device
Serious events: 538 serious events
Other events: 0 other events
Deaths: 161 deaths
Serious adverse events
| Measure |
Subjects Implanted With Amulet Device
n=1088 participants at risk
All subjects who received the Amulet device were followed.
Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Acute bacterial endocarditis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Acute erosive gastritis
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Acute renal failure
|
1.8%
20/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Acute subdural hematoma
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome(ARDS)
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Air embolus
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Alcohol intoxication
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Blood and lymphatic system disorders
Anemias
|
2.4%
26/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Angina pectoris
|
0.74%
8/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Aortic dissection
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Aortic value stenosis
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Aphasia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arm fracture
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Arterial hypertension/Hypertension
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Ascites
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Aspiration Pneumonia/Necrotizing pneumonia/Aspiration of vomitus
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
37/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Atrial flutter
|
0.74%
8/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Atrial tachycardia
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Atrioventricular block
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Bacterial infection
|
1.7%
19/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Bacterial infections of the skin
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Benign Tumors
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Blood and lymphatic system disorders
Bleeding
|
0.55%
6/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Brain Tumor
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Burns
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.1%
23/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Cardiac Arrest
|
1.1%
12/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Cardiac Decompensation
|
1.4%
15/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Cardiac Perforation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Cellulitis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Cerebral Aneurysm
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Chest Pain
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Hepatobiliary disorders
Choledocholithiaisis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Chronic Renal Failure
|
0.55%
6/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Chronic Subdural Hematoma
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Clostridum difficile Infection
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Psychiatric disorders
Cognitive Impairment
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Colitis
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Confusion
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.2%
13/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Constipation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Skin and subcutaneous tissue disorders
Cutaneous Abcesses
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Cystitis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Decompensated Heart Failure
|
5.7%
62/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Deep Vein/Venous Thrombosis
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Psychiatric disorders
Delirium
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Dementia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Surgical and medical procedures
Device Embolization
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Endocrine disorders
Diabetes Mellitus
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Diarrhea
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Diverticulosis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Drug Side Effect
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Dyspnea
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
EKG Abnormalities
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Surgical and medical procedures
Elective Cardiac Surgery
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Emesis/Vomiting
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Encephalopathy
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Epididymitis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Eye disorders
Eye Bleed
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
9/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Fever
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.55%
6/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Fungal Skin Infection
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Gastritis
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
5.2%
57/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Generalized Seizures
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Eye disorders
Glaucoma
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Gout
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Psychiatric disorders
Hallucinations
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Heart Block
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Heart Failure
|
0.55%
6/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Heartburn
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Hematemesis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Hematochezia
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Hematoma
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Hematuria
|
1.1%
12/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Hemiblock (Fascicular Block)
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Hemoperitoneum
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Hemoptysis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Hepatobiliary disorders
Hepatic and Biliary Disorders
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Congenital, familial and genetic disorders
Hernia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Hip Dislocation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Hypertensive Crisis
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Hypokalemia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Hypotension
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Hypothermia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Infective/Bacterial Endocarditis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Intracerebral Haemorrhage
|
0.92%
10/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Iron-Deficiency Anemia
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Ischemic Stroke
|
3.6%
39/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Blood and lymphatic system disorders
Leukemias
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spondylosis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Blood and lymphatic system disorders
Melena
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Miscellaneous Infections
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
0.46%
5/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Multiple Organ Failure
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Myocardial Infarction
|
0.92%
10/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Neurological Hematoma
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Eye disorders
Ocular Hemorrhage
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Congenital, familial and genetic disorders
Osler Weber Rendu Syndrome
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis/Degenerative Joint Disease
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Overdose
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Pain
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Parkinson's Disease
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Paroxysmal Atrial Tachycardia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Gastrointestinal disorders
Perforated Appendix
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Pericardial Effusion
|
0.83%
9/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Pericardial Tamponade
|
1.0%
11/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Peripheral Arterial Occlusion
|
0.55%
6/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Peripheral Vascular Disease
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Persistent Atrial Fibrillation
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.0%
33/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Caused By Gram-Negative Bacilli
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia in the Compromised Host
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Polyneuropathy
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Portal-Systemic Encephalopathy
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Skin and subcutaneous tissue disorders
Pressure Sores
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Presyncope
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Hepatobiliary disorders
Primary Biliary Cirrhosis
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Psychiatric disorders
Psychogenic Event
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Pulmonary Embolism
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Raynaud's Syndrome
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Renal Failure
|
0.83%
9/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
Respiratory Failure
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Rheumotologic Disease
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Second Degree Heart Block
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
1.3%
14/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Sepsis
|
1.7%
19/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Septicemia
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Shock
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Simple Partial Seizures
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.18%
2/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Status Epilepticus
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Stroke
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Subdural Haemorrhage
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Psychiatric disorders
Suicide Attempt
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Sustained Atrial Fibrillation
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Syncope
|
1.0%
11/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
TEE-Related Event
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Thrombus
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Thrombus on Device
|
1.7%
19/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Torsade de Pointes
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Transient Ischemic Attack (TIA)
|
1.3%
14/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Trauma
|
0.83%
9/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Valve
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Unstable Angina
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Urethral Dysfunction
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Urinary Retention
|
0.64%
7/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Renal and urinary disorders
Urinary Tract Infections
|
1.0%
11/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Surgical and medical procedures
VASC AV Fistula
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
VASC Bleeding
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
VASC Hematoma
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Injury, poisoning and procedural complications
VASC Pseudoaneurysm
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Vascular Dissection
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Vascular Ischemia
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Nervous system disorders
Vaso Vagal Response
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.28%
3/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.37%
4/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Vascular disorders
Vessel Occlusion
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
Infections and infestations
Viral Syndrome
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Weakness
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Wound Dehiscence
|
0.09%
1/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
|
General disorders
Other
|
4.6%
50/1088 • 2 years
Non-serious adverse event information was not analyzed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place