Comparing the Effectiveness of Repairing Versus Replacing... | NCT00807040

ID	Type	Description	Link
U01HL088942	U.S. NIH Grant/Contract		View source
U01 HL088942-01-2
595	Other Identifier	Ct Surgery Network Research Group

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Description Module

Detailed Description

CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. After a heart attack, some people may develop a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR), and it can cause blood to flow backward into the heart. If left untreated, severe IMR can lead to heart failure or serious heart rhythm irregularities, known as arrhythmias. People with severe mitral valve leakage routinely undergo one of two surgical procedures to fix the mitral valve: a mitral valve repair procedure, in which a surgical ring is used to repair the valve; or a mitral valve replacement procedure, in which the damaged valve is replaced with a new one. Currently, there is no consensus in the medical community as to which procedure is more beneficial. The purpose of this study is to determine whether people with severe mitral valve regurgitation should undergo a mitral valve repair procedure or a mitral valve replacement procedure.

This study will enroll people with CAD who have severe mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Day 30 and Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Label	Type	Description	Intervention Names
Mitral Valve Repair with Annuloplasty	Active Comparator	Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.	Procedure: Mitral Valve Repair with Annuloplasty
Mitral Valve Replacement	Active Comparator	Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.	Procedure: Mitral Valve Replacement

Name	Type	Description	Arm Group Labels	Other Names
Mitral Valve Repair with Annuloplasty	Procedure	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.

Measure	Description	Time Frame
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)		Measured at Month 12

Measure	Description	Time Frame
All-cause Mortality		Measured at Month 24

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO ≥ 0.4 cmsq. If ERO < 0.4, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
Eligible for surgical repair and replacement of mitral valve
CAD with or without the need for coronary revascularization

Exclusion Criteria:

Any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
Prior mitral valve repair
Severe irreversible pulmonary hypertension in the judgment of the investigator
Medically unable to undergo cardiopulmonary bypass (CPB)
Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
Planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [PFO] or atrial septal defect [ASD] or Maze procedure)
Clinical signs of cardiogenic shock at the time of surgery
Treatment with long-term intravenous inotropic therapy at the time of surgery
ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
Congenital heart disease (except PFO or ASD)
Evidence of cirrhosis or liver synthetic failure
Excessive surgical risk, as judged by the surgical investigator
Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
Any concurrent disease with a life expectancy of less than 2 years
Pregnant

Name	Affiliation	Role
Timothy Gardner, MD	Christiana Care Health Services	Study Chair
Patrick O'Gara, MD	Brigham and Women's Hospital	Study Chair
Annetine C. Gelijns, Ph.D.	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Los Angeles	California	90033	United States
Emory University

PubMed Identifier	Type	Citation	Retractions
24245543	Result	Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL; CTSN. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014 Jan 2;370(1):23-32. doi: 10.1056/NEJMoa1312808. Epub 2013 Nov 18.
33573741

Label	URL
Click here for the Cardiothoracic Surgical Trials Network Web site.	View source

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)

Posted

Mean

Standard Deviation

ml per square meter of body-surface area

Measured at Month 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000126 OG001125

Title

Denominators

Categories

Title	Measurements
	OG00054.6± 25.0 OG00160.7± 31.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.	Wilcoxon (Mann-Whitney)		0.18														Other	We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.

Secondary

All-cause Mortality

Posted

Count of Participants

Participants

Measured at Month 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bleeding	Blood and lymphatic system disorders	Systematic Assessment	EG0007 events6 affected126 at risk EG00110 events10 affected125 at risk
Arrhythmias - Sustained ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG00012 events10 affected126 at risk EG00117 events12 affected125 at risk
Arrhythmias - Sustained supraventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG00026 events23 affected126 at risk EG00119 events18 affected125 at risk
Pericardial Fluid Collection	Cardiac disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0011 events1 affected125 at risk
Hepatic Dysfunction	Hepatobiliary disorders	Systematic Assessment	EG0005 events5 affected126 at risk EG0015 events5 affected125 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment	EG00025 events21 affected126 at risk EG00129 events21 affected125 at risk
Major Infection - Endocarditis	Infections and infestations	Systematic Assessment	EG0000 events0 affected126 at risk EG0012 events2 affected125 at risk
Major Infection - Sepsis	Infections and infestations	Systematic Assessment	EG00012 events11 affected126 at risk EG0016 events6 affected125 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0005 events4 affected126 at risk EG0011 events1 affected125 at risk
Myocardial infarction - Peri-CABG MI	Cardiac disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0012 events2 affected125 at risk
Neurological Dysfunction - TIA	Nervous system disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Neurological Dysfunction - CVA-Ischemic	Nervous system disorders	Systematic Assessment	EG00010 events8 affected126 at risk EG0016 events6 affected125 at risk
Neurological Dysfunction - CVA-Hemorrhagic	Nervous system disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0010 events0 affected125 at risk
Neurological Dysfunction - Toxic Metabolic Encephalopathy	Nervous system disorders	Systematic Assessment	EG0003 events2 affected126 at risk EG0011 events1 affected125 at risk
Neurological Dysfunction - Other	Nervous system disorders	Systematic Assessment	EG0004 events4 affected126 at risk EG0012 events2 affected125 at risk
Renal dysfunction (no dialysis)	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected126 at risk EG0017 events7 affected125 at risk
Renal failure (dialysis)	Renal and urinary disorders	Systematic Assessment	EG0006 events6 affected126 at risk EG00111 events11 affected125 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events12 affected126 at risk EG00119 events18 affected125 at risk
Heart Failure	Cardiac disorders	Systematic Assessment	EG00048 events30 affected126 at risk EG00129 events23 affected125 at risk
Venous Thromboembolism Event	Vascular disorders	Systematic Assessment	EG0004 events4 affected126 at risk EG0011 events1 affected125 at risk
Wound Dehiscence	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00015 events12 affected126 at risk EG0019 events8 affected125 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected126 at risk EG0012 events2 affected125 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0012 events2 affected125 at risk
Altered Mental Status	Nervous system disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0012 events1 affected125 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Aortic Disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Arrhythmia - Undifferentiated	Cardiac disorders	Systematic Assessment	EG0009 events9 affected126 at risk EG0017 events7 affected125 at risk
Broken bone	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 events5 affected126 at risk EG0011 events1 affected125 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected126 at risk EG0011 events1 affected125 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected126 at risk EG0016 events6 affected125 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Cardiac conduction abnormalities requiring permanent pacemaker	Cardiac disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0011 events1 affected125 at risk
Carotid Disease	Vascular disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Chest Pain	Cardiac disorders	Systematic Assessment	EG00013 events3 affected126 at risk EG0011 events1 affected125 at risk
Coagulopathy/HIT	Blood and lymphatic system disorders	Systematic Assessment	EG0004 events4 affected126 at risk EG0012 events2 affected125 at risk
Collapsed lung	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0011 events1 affected125 at risk
Failure to thrive	General disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
GI Bleed/GI Issue	Gastrointestinal disorders	Systematic Assessment	EG00012 events9 affected126 at risk EG00113 events10 affected125 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Hemi-diaphragm paralysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Hemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Hypoxic Ischemic Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Inguinal Hernia Surgery	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Knee arthroplasty	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Left Atrial Thrombus	Cardiac disorders	Systematic Assessment	EG0004 events4 affected126 at risk EG0010 events0 affected125 at risk
Orthostatic hypotension	Cardiac disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
PM or ICD Implant/Revision	Cardiac disorders	Systematic Assessment	EG0007 events7 affected126 at risk EG0017 events6 affected125 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0011 events1 affected125 at risk
Penetrating Thoracic Ulcer	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Peripheral arterial disease	Vascular disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0011 events1 affected125 at risk
Re-Operation for Severe Mitral Valve Leakage	Cardiac disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Right Hip Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Right groin pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
SIRS	General disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Syncope	Cardiac disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0012 events1 affected125 at risk
Urinary retention/obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Vasoplegia	Vascular disorders	Systematic Assessment	EG0003 events3 affected126 at risk EG0016 events6 affected125 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Volume Overload	Cardiac disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
non-cardiac musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bleeding	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Arrhythmias - Sustained supraventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG00011 events10 affected126 at risk EG00112 events12 affected125 at risk
Hepatic Dysfunction	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0013 events3 affected125 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment	EG00013 events11 affected126 at risk EG00121 events17 affected125 at risk
Myocardial infarction - Peri-Percutaneous Intervention MI	Cardiac disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Neurological Dysfunction - Toxic Metabolic Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Neurological Dysfunction - Other*	Nervous system disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Renal dysfunction (no dialysis)	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected126 at risk EG0014 events4 affected125 at risk
Renal failure (dialysis)	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0012 events2 affected125 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0013 events3 affected125 at risk
Heart Failure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0011 events1 affected125 at risk
Arterial Non-CNS Thromboembolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Venous Thromboembolism Event	Vascular disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0019 events7 affected125 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Acute Kidney Injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Arrhythmia - Undifferentiated	Cardiac disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0012 events2 affected125 at risk
Broken bone	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0012 events1 affected125 at risk
Carpal tunnel syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Coagulopathy/HIT	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0013 events3 affected125 at risk
Dizziness	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected126 at risk EG0011 events1 affected125 at risk
GI Bleed/GI Issue	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0010 events0 affected125 at risk
Glaucoma	Eye disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Left groin lymphocele/seroma	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected126 at risk EG0010 events0 affected125 at risk
Urinary retention/obstruction	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected126 at risk EG0010 events0 affected125 at risk

ID	Term
D008944	Mitral Valve Insufficiency
D003324	Coronary Artery Disease

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	24	126	89	126	33	126
EG001	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.	29	125	88	125	44	125