Trial Outcomes & Findings for Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation (NCT NCT00806988)
NCT ID: NCT00806988
Last Updated: 2017-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
Measured at Month 12
Results posted on
2017-06-26
Participant Flow
Participant milestones
| Measure |
CABG
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
Mitral Valve Repair
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
150
|
|
Overall Study
COMPLETED
|
108
|
123
|
|
Overall Study
NOT COMPLETED
|
43
|
27
|
Reasons for withdrawal
| Measure |
CABG
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
Mitral Valve Repair
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
|---|---|---|
|
Overall Study
Death
|
16
|
15
|
|
Overall Study
Withdrawal by Subject
|
8
|
8
|
|
Overall Study
Lost to Follow-up
|
19
|
4
|
Baseline Characteristics
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Baseline characteristics by cohort
| Measure |
Mitral Valve Repair
n=150 Participants
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
CABG
n=151 Participants
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
275 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 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
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
237 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
114 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 12Outcome measures
| Measure |
Mitral Valve Repair
n=150 Participants
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
CABG
n=151 Participants
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
|---|---|---|
|
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
|
49.6 ml per square meter
Standard Deviation 31.5
|
46.1 ml per square meter
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: Measured at Month 24Outcome measures
| Measure |
Mitral Valve Repair
n=150 Participants
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
CABG
n=151 Participants
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
|---|---|---|
|
Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention
|
46 Participants
|
48 Participants
|
Adverse Events
Mitral Valve Repair
Serious events: 88 serious events
Other events: 44 other events
Deaths: 15 deaths
CABG
Serious events: 79 serious events
Other events: 37 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Mitral Valve Repair
n=150 participants at risk
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
CABG
n=151 participants at risk
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
1.3%
2/150 • Number of events 2 • 2 years
|
3.3%
5/151 • Number of events 6 • 2 years
|
|
Cardiac disorders
Arrhythmias - Sustained ventricular arrhythmia
|
2.7%
4/150 • Number of events 4 • 2 years
|
3.3%
5/151 • Number of events 5 • 2 years
|
|
Cardiac disorders
Arrhythmias - Sustained supraventricular arrhythmia
|
14.7%
22/150 • Number of events 24 • 2 years
|
7.3%
11/151 • Number of events 11 • 2 years
|
|
Cardiac disorders
Pericardial Fluid Collection
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Infections and infestations
Major Infection - Localized
|
12.0%
18/150 • Number of events 25 • 2 years
|
9.9%
15/151 • Number of events 22 • 2 years
|
|
Cardiac disorders
Major Infection - Endocarditis
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Infections and infestations
Major Infection - Sepsis
|
5.3%
8/150 • Number of events 9 • 2 years
|
4.0%
6/151 • Number of events 7 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
1/150 • Number of events 1 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Cardiac disorders
Myocardial infarction - Peri-CABG MI
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Myocardial infarction - Peri-Percutaneous Intervention MI
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - TIA
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Ischemic
|
4.0%
6/150 • Number of events 6 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Hemorrhagic
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
2.0%
3/150 • Number of events 3 • 2 years
|
0.00%
0/151 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Other
|
2.7%
4/150 • Number of events 4 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal dysfunction (no dialysis)
|
4.7%
7/150 • Number of events 7 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Renal failure (dialysis)
|
3.3%
5/150 • Number of events 6 • 2 years
|
4.0%
6/151 • Number of events 7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.0%
9/150 • Number of events 10 • 2 years
|
5.3%
8/151 • Number of events 9 • 2 years
|
|
Cardiac disorders
Heart Failure
|
17.3%
26/150 • Number of events 40 • 2 years
|
17.2%
26/151 • Number of events 39 • 2 years
|
|
Vascular disorders
Arterial Non-CNS Thromboembolism
|
0.00%
0/150 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Vascular disorders
Venous Thromboembolism Event
|
2.7%
4/150 • Number of events 4 • 2 years
|
2.0%
3/151 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
2.0%
3/150 • Number of events 3 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.0%
9/150 • Number of events 12 • 2 years
|
5.3%
8/151 • Number of events 9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/150 • 2 years
|
4.0%
6/151 • Number of events 6 • 2 years
|
|
Cardiac disorders
2 Degree AV Block Type 1
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Vascular disorders
Abdominal Aortic Aneurysm with claudication
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Infections and infestations
Abscess
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Eye disorders
Acute vision loss, non-neurological
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
4/150 • Number of events 5 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Annuloplasty ring dehiscence
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Bradyarrhythmia requiring pacemaker
|
3.3%
5/150 • Number of events 5 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Cardiac disorders
Bradycardia
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
Bradycardia requiring pacemaker
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Broken Bone
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.3%
2/150 • Number of events 3 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiogenic Shock
|
0.67%
1/150 • Number of events 1 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Cardiac disorders
Carotid Disease
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Chest Pain/ACS
|
2.0%
3/150 • Number of events 3 • 2 years
|
6.6%
10/151 • Number of events 15 • 2 years
|
|
Cardiac disorders
Chest Pain/ACS/PCI
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy/HIT
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy/HIT (-)
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Contrast induced nephropathy
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression and anxiety
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Diabetic Foot Ulcer
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Epistaxis
|
0.67%
1/150 • Number of events 2 • 2 years
|
0.00%
0/151 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Gastrointestinal disorders
GI Bleed/GI Issue
|
4.7%
7/150 • Number of events 7 • 2 years
|
4.0%
6/151 • Number of events 6 • 2 years
|
|
Vascular disorders
Gangrenous Toe
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Heart Transplant
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
2/150 • Number of events 2 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypertension
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.00%
0/151 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia and respiratory insufficiency
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
ICD Implant
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.00%
0/151 • 2 years
|
|
Gastrointestinal disorders
Ischemic Bowel
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Ischemic Left hand
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
LV apical cannula clot
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Vascular disorders
Left superficial femoral artery pseudoaneurysm
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Vascular disorders
Lower extremity ischemia
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
Malfunctioning PM
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
Non Sustained VT
|
2.0%
3/150 • Number of events 3 • 2 years
|
0.00%
0/151 • 2 years
|
|
Skin and subcutaneous tissue disorders
Non-healing wound
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Organ Transplant
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Pericarditis
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Vascular disorders
Peripheral vascular disease
|
0.67%
1/150 • Number of events 1 • 2 years
|
2.0%
3/151 • Number of events 5 • 2 years
|
|
Vascular disorders
Peripheral vascular disease/BKA
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Pill esophagitis
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Post anesthetic Hypoxia
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
R/O LV Thrombus
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Renal and urinary disorders
Renal Calculi
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Gastrointestinal disorders
Small bowel obstruction/ileus
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Sternal Non-Union
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Cardiac disorders
Syncope
|
2.0%
3/150 • Number of events 3 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Torn aorta
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Blood and lymphatic system disorders
Hemostasis
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Nephrectomy
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Blood and lymphatic system disorders
Right Axillary hematoma
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Gastrointestinal disorders
Ruptured appendix
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Mitral Valve Repair
n=150 participants at risk
Participants will undergo CABG and a mitral valve repair procedure.
Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
2. The heart will be arrested with cardioplegia.
3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.
CABG: CABG will be performed using
|
CABG
n=151 participants at risk
Participants will undergo CABG.
CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
|---|---|---|
|
Cardiac disorders
Arrhythmias - Sustained supraventricular arrhythmia
|
16.0%
24/150 • Number of events 25 • 2 years
|
11.9%
18/151 • Number of events 18 • 2 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Infections and infestations
Major Infection - Localized
|
8.7%
13/150 • Number of events 19 • 2 years
|
6.0%
9/151 • Number of events 11 • 2 years
|
|
Cardiac disorders
Myocardial infarction - Peri-CABG MI
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
2.7%
4/150 • Number of events 4 • 2 years
|
0.00%
0/151 • 2 years
|
|
Nervous system disorders
Neurological Dysfunction - Other*
|
1.3%
2/150 • Number of events 2 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal dysfunction (no dialysis)
|
2.7%
4/150 • Number of events 4 • 2 years
|
0.00%
0/151 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Venous Thromboembolism Event
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.0%
6/150 • Number of events 6 • 2 years
|
4.6%
7/151 • Number of events 7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/150 • 2 years
|
1.3%
2/151 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
GI Bleed/GI Issue
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Hemetemesis
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Vascular disorders
Pressure ulcers
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Vascular disorders
Neurological Dysfunction - TIA
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Cardiac disorders
Bradyarrhythmia requiring pacemaker
|
0.67%
1/150 • Number of events 1 • 2 years
|
0.00%
0/151 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Non-healing wound
|
0.00%
0/150 • 2 years
|
0.66%
1/151 • Number of events 1 • 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