Trial Outcomes & Findings for Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation (NCT NCT00807040)
NCT ID: NCT00807040
Last Updated: 2019-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
251 participants
Primary outcome timeframe
Measured at Month 12
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
Mitral Valve Repair With Annuloplasty
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
125
|
|
Overall Study
COMPLETED
|
90
|
84
|
|
Overall Study
NOT COMPLETED
|
36
|
41
|
Reasons for withdrawal
| Measure |
Mitral Valve Repair With Annuloplasty
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
Overall Study
Death
|
24
|
29
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
Baseline Characteristics
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Baseline characteristics by cohort
| Measure |
Mitral Valve Repair With Annuloplasty
n=126 Participants
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
n=125 Participants
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 12Outcome measures
| Measure |
Mitral Valve Repair With Annuloplasty
n=126 Participants
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
n=125 Participants
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
|
54.6 ml per square meter of body-surface area
Standard Deviation 25.0
|
60.7 ml per square meter of body-surface area
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Measured at Month 24Outcome measures
| Measure |
Mitral Valve Repair With Annuloplasty
n=126 Participants
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
n=125 Participants
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
All-cause Mortality
|
24 Participants
|
29 Participants
|
Adverse Events
Mitral Valve Repair With Annuloplasty
Serious events: 89 serious events
Other events: 33 other events
Deaths: 24 deaths
Mitral Valve Replacement
Serious events: 88 serious events
Other events: 44 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Mitral Valve Repair With Annuloplasty
n=126 participants at risk
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
n=125 participants at risk
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
4.8%
6/126 • Number of events 7 • 2 years
|
8.0%
10/125 • Number of events 10 • 2 years
|
|
Cardiac disorders
Arrhythmias - Sustained ventricular arrhythmia
|
7.9%
10/126 • Number of events 12 • 2 years
|
9.6%
12/125 • Number of events 17 • 2 years
|
|
Cardiac disorders
Arrhythmias - Sustained supraventricular arrhythmia
|
18.3%
23/126 • Number of events 26 • 2 years
|
14.4%
18/125 • Number of events 19 • 2 years
|
|
Cardiac disorders
Pericardial Fluid Collection
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
4.0%
5/126 • Number of events 5 • 2 years
|
4.0%
5/125 • Number of events 5 • 2 years
|
|
Infections and infestations
Major Infection - Localized
|
16.7%
21/126 • Number of events 25 • 2 years
|
16.8%
21/125 • Number of events 29 • 2 years
|
|
Infections and infestations
Major Infection - Endocarditis
|
0.00%
0/126 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Infections and infestations
Major Infection - Sepsis
|
8.7%
11/126 • Number of events 12 • 2 years
|
4.8%
6/125 • Number of events 6 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
4/126 • Number of events 5 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Myocardial infarction - Peri-CABG MI
|
0.00%
0/126 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - TIA
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Ischemic
|
6.3%
8/126 • Number of events 10 • 2 years
|
4.8%
6/125 • Number of events 6 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Hemorrhagic
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.00%
0/125 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
1.6%
2/126 • Number of events 3 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Other
|
3.2%
4/126 • Number of events 4 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Renal dysfunction (no dialysis)
|
3.2%
4/126 • Number of events 4 • 2 years
|
5.6%
7/125 • Number of events 7 • 2 years
|
|
Renal and urinary disorders
Renal failure (dialysis)
|
4.8%
6/126 • Number of events 6 • 2 years
|
8.8%
11/125 • Number of events 11 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
9.5%
12/126 • Number of events 14 • 2 years
|
14.4%
18/125 • Number of events 19 • 2 years
|
|
Cardiac disorders
Heart Failure
|
23.8%
30/126 • Number of events 48 • 2 years
|
18.4%
23/125 • Number of events 29 • 2 years
|
|
Vascular disorders
Venous Thromboembolism Event
|
3.2%
4/126 • Number of events 4 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.5%
12/126 • Number of events 15 • 2 years
|
6.4%
8/125 • Number of events 9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
3/126 • Number of events 3 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/126 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Nervous system disorders
Altered Mental Status
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.80%
1/125 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Vascular disorders
Aortic Disease
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Arrhythmia - Undifferentiated
|
7.1%
9/126 • Number of events 9 • 2 years
|
5.6%
7/125 • Number of events 7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Broken bone
|
4.0%
5/126 • Number of events 6 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.4%
3/126 • Number of events 3 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.79%
1/126 • Number of events 1 • 2 years
|
4.8%
6/125 • Number of events 6 • 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac conduction abnormalities requiring permanent pacemaker
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Vascular disorders
Carotid Disease
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Cardiac disorders
Chest Pain
|
2.4%
3/126 • Number of events 13 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy/HIT
|
3.2%
4/126 • Number of events 4 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Collapsed lung
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
General disorders
Failure to thrive
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Gastrointestinal disorders
GI Bleed/GI Issue
|
7.1%
9/126 • Number of events 12 • 2 years
|
8.0%
10/125 • Number of events 13 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemi-diaphragm paralysis
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Nervous system disorders
Hypoxic Ischemic Encephalopathy
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Surgical and medical procedures
Inguinal Hernia Surgery
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Left Atrial Thrombus
|
3.2%
4/126 • Number of events 4 • 2 years
|
0.00%
0/125 • 2 years
|
|
Cardiac disorders
Orthostatic hypotension
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
PM or ICD Implant/Revision
|
5.6%
7/126 • Number of events 7 • 2 years
|
4.8%
6/125 • Number of events 7 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Penetrating Thoracic Ulcer
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Vascular disorders
Peripheral arterial disease
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Re-Operation for Severe Mitral Valve Leakage
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Hip Pain
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Vascular disorders
Right groin pseudoaneurysm
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
General disorders
SIRS
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Cardiac disorders
Syncope
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.80%
1/125 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Urinary retention/obstruction
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Vascular disorders
Vasoplegia
|
2.4%
3/126 • Number of events 3 • 2 years
|
4.8%
6/125 • Number of events 6 • 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Cardiac disorders
Volume Overload
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Musculoskeletal and connective tissue disorders
non-cardiac musculoskeletal chest pain
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Mitral Valve Repair With Annuloplasty
n=126 participants at risk
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
Mitral Valve Replacement
n=125 participants at risk
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Cardiac disorders
Arrhythmias - Sustained supraventricular arrhythmia
|
7.9%
10/126 • Number of events 11 • 2 years
|
9.6%
12/125 • Number of events 12 • 2 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
1.6%
2/126 • Number of events 2 • 2 years
|
2.4%
3/125 • Number of events 3 • 2 years
|
|
Infections and infestations
Major Infection - Localized
|
8.7%
11/126 • Number of events 13 • 2 years
|
13.6%
17/125 • Number of events 21 • 2 years
|
|
Cardiac disorders
Myocardial infarction - Peri-Percutaneous Intervention MI
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Other*
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal dysfunction (no dialysis)
|
2.4%
3/126 • Number of events 3 • 2 years
|
3.2%
4/125 • Number of events 4 • 2 years
|
|
Renal and urinary disorders
Renal failure (dialysis)
|
1.6%
2/126 • Number of events 2 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/126 • 2 years
|
2.4%
3/125 • Number of events 3 • 2 years
|
|
Cardiac disorders
Heart Failure
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Vascular disorders
Arterial Non-CNS Thromboembolism
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Vascular disorders
Venous Thromboembolism Event
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
2/126 • Number of events 2 • 2 years
|
5.6%
7/125 • Number of events 9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Cardiac disorders
Arrhythmia - Undifferentiated
|
0.00%
0/126 • 2 years
|
1.6%
2/125 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Broken bone
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy/HIT
|
0.00%
0/126 • 2 years
|
2.4%
3/125 • Number of events 3 • 2 years
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/126 • 2 years
|
0.80%
1/125 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
GI Bleed/GI Issue
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.00%
0/125 • 2 years
|
|
Eye disorders
Glaucoma
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Blood and lymphatic system disorders
Left groin lymphocele/seroma
|
0.79%
1/126 • Number of events 1 • 2 years
|
0.00%
0/125 • 2 years
|
|
Renal and urinary disorders
Urinary retention/obstruction
|
1.6%
2/126 • Number of events 2 • 2 years
|
0.00%
0/125 • 2 years
|
Additional Information
Alan Moskowitz, MD
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place