Evaluating the Benefit of Concurrent Tricuspid Valve Repa... | NCT02675244

NCT02675244

ID	Type	Description	Link
2U01HL088942-07	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
German Society for Thoracic and Cardiovascular Surgery	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MVS Alone	Active Comparator	Participants will undergo mitral valve surgery alone.	Procedure: MVS
MVS + TV Annuloplasty	Active Comparator	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.	Procedure: TV Annuloplasty Procedure: MVS

Name	Type	Description	Arm Group Labels	Other Names
TV Annuloplasty	Procedure	TV Annuloplasty will be performed using standard surgical techniques	MVS + TV Annuloplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Treatment Failure	The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.	24 Months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Major Adverse Cardiac and Cerebrovascular Events (MACCE) is defined as a non-weighted composite score comprised of the following components: Death, Stroke, and Serious heart failure events	up to 24 Months
Number of Participants With NYHA Classification I-IV

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing MVS for degenerative MR* with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and none/trace or mild TR, determined by echocardiography.
Age ≥ 18 years
Able to sign Informed Consent and Release of Medical Information forms
- "Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions . . ., such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse." This definition excludes rheumatic heart disease. (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6).

Exclusion Criteria:

Functional MR
Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator
Structural / organic TV disease
Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE)
Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle
Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG
Cardiogenic shock at the time of randomization
STEMI requiring intervention within 7 days prior to randomization
Evidence of cirrhosis or hepatic synthetic failure
Severe, irreversible pulmonary hypertension in the judgment of the investigator
Pregnancy at the time of randomization
Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
Any concurrent disease with life expectancy < 2 years
Unable or unwilling to provide informed consent
Unable or unwilling to comply with study follow up in the opinion of the investigator

Contacts/Locations Module

Name	Affiliation	Role
Annetine C. Gelijns, PhD	Icahn School of Medicine at Mount Sinai	Principal Investigator
Richard Weisel, MD	Toronto General Hospital	Study Chair

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41706073	Derived	Chu MWA, Raymond S, Gelijns AC, Moskowitz AJ, Borger MA, Mack M, Hung J, Voisine P, Gammie JS, Krane M, Yerokun BA, Bowdish ME, Conradi L, Bolling SF, Taddei-Peters WC, Jeffries NO, Marks ME, Gupta L, Iribarne A, Beyersdorf F, Bagiella E, Geirsson A, Overbey JR, Gillinov M, O'Gara PT, Ailawadi G, Falk V. Mitral Valve Repair for Degenerative MR With Moderate or Less Tricuspid Regurgitation: 2-Year Outcomes From a Multicenter Echocardiographic Core Laboratory-Adjudicated Cohort. J Am Coll Cardiol. 2026 Feb 18:S0735-1097(25)10598-6. doi: 10.1016/j.jacc.2025.12.065. Online ahead of print.
36669972

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
FG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 1, 2020	Nov 8, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
BG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.2± 9.7 BG00166.6± 10.7 BG00267.4± 10.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00050 BG00151 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00043 BG00144 BG002

Tricuspid-valve annulus dimension (mm)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00042.2± 4.7 BG00142.0± 4.6 BG002

Tricuspid Regurgitation

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Moderate	BG00076 BG00173 BG002

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

Percentage of Participants With Treatment Failure

The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.

Posted

Number

95% Confidence Interval

percentage of participants

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000203 OG001198

Title

Denominators

Categories

Title	Measurements
	OG00010.2(6.0 to 14.5) OG0013.9(1.1 to 6.7)

Secondary

Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Major Adverse Cardiac and Cerebrovascular Events (MACCE) is defined as a non-weighted composite score comprised of the following components: Death, Stroke, and Serious heart failure events

Posted

Count of Participants

Participants

up to 24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Number of Participants With NYHA Classification I-IV

Functional status will be assessed by the New York Heart Association (NYHA) Classification scale which ranges from 1 (no physical limitations) to 4 (severe limitation of physical activity).

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
No NYHA class listed or unable to determine

Posted

Count of Participants

Participants

at 24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Secondary

Diuretic Use

The diuretic requirements of patients will be assessed.

Patients with known diuretic status at 24 months

Posted

Count of Participants

Participants

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Six Minute Walk Test

The total distance, in feet, walked in six minutes

Patients with observed 6MWT at 24 months

Posted

Median

Inter-Quartile Range

feet

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Number of Participants With Degree of TR

Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.

Posted

Count of Participants

Participants

up to 24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Right Ventricular Size

Not Posted

24 Months

Participants

Secondary

Number of Participants With Normal RV Function

Number of Participants with Normal RV Function assessed by echocardiography.

Patients with observed RV Function at 24 months

Posted

Count of Participants

Participants

up to 24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Peak Tricuspid Annular Velocity

Not Posted

24 Months

Participants

Secondary

Tricuspid Annular Peak Systolic Excursion (TAPSE)

Degree of RV function assessed by TAPSE

Not Posted

24 Months

Participants

Secondary

Right Ventricular Fractional Area Change (RVFAC)

Degree of RV function assessed by RVFAC

Not Posted

24 Months

Participants

Secondary

Pulmonary Artery Pressure

Pulmonary artery pressure assessed by echocardiography.

Not Posted

up to 24 Months

Participants

Secondary

Right Ventricular Volume

RV Volume as measured by transthoracic 3D echocardiography.

Not Posted

24 Months

Participants

Secondary

SF-12

Quality of Life assessed by SF-12. A measure of perceived health (health-related quality of life [QoL]) that describes the degree of general physical health status and mental health distress. Higher scores indicate higher levels of health. The physical and mental health scores on the 12-Item Short Form Survey (SF-12) are reported as T scores (mean, 50±10, 50 indicates the population mean with a standard deviation of 10), with higher scores indicating better health status.

Patients with observed SF-12 at 24 months

Posted

Mean

Standard Deviation

T-Score

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants

Secondary

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Quality of Life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life, in which higher scores reflect better health status. Scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary range from 0 to 100, with higher scores indicating a better quality of life and fewer symptoms and physical limitations associated with heart failure.

Patients with observed KCCQ at 24 months

Posted

Mean

Standard Deviation

score on a scale

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts

Secondary

EuroQoL (EQ-5D)

Quality of Life assessed by EuroQoL (EQ-5D) - a standardised instrument for use as a measure of health outcome. Scores on the EuroQol (EQ-5D) visual analogue scale range from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate higher levels of health.

Patients with observed Euro-QOL

Posted

Mean

Standard Deviation

score on a scale

24 Months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Survival

Incidence of participants alive

Not Posted

up to 60 Months

Participants

Secondary

Length of Index Hospitalization

Post-surgery hospital LOS between treatment groups compared, separately by region. 1 Canadian patient in the MVS+TA group withdrew prior to discharge from the index hospitalization so do not have their LOS

Posted

Median

Inter-Quartile Range

days

average 30 days

ID	Title	Description
OG000	MVS Alone - US	MVS Alone (as described previously) patients randomized in the US
OG001	MVS + TA - US	MVS +TA (as described previously) patients randomized in the US
OG002	MVS Alone - Canada	MVS Alone (as described previously) patients randomized in the Canada
OG003	MVS + TA - Canada	MVS +TA (as described previously) patients randomized in the Canada
OG004	MVS Alone - Germany	MVS Alone (as described previously) patients randomized in Germany

Secondary

Number of Participants With Readmission

Incidence of readmissions

*2 patients in the MVS alone and 3 patients in the MVS+TA group died during the index hospitalization, 1 patient in the MVS+TA group withdrew prior to discharge from the index hospitalization - these patients are excluded from analyses of readmission by 2 years post-randomization

Posted

Count of Participants

Participants

up to 24 months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Number of Participants With TV Reoperations

Number of participants with TV reoperations

Posted

Count of Participants

Participants

up to 24 months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Economic Measures (Inpatient Costs)

Inpatient costs will be measured through the collection of hospital billing.

Not Posted

up to 60 months

Participants

Secondary

Number of Participants With Serious Adverse Events

Safety as measured by frequency of serious adverse events.

Posted

Count of Participants

Participants

24 months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Secondary

Gait Speed Test

Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks

Patients with observed gait speed test at 24 months

Posted

Median

Inter-Quartile Range

m/s

24 months

ID	Title	Description
OG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques
OG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MVS Alone	Participants will undergo mitral valve surgery alone. MVS: MVS will be performed using standard surgical techniques	9	203	109	203	74	203
EG001	MVS + TV Annuloplasty	Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques MVS: MVS will be performed using standard surgical techniques	6	198	109	198	61	198

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Bleeding	Vascular disorders	Systematic Assessment		EG00013 events12 affected203 at risk EG0018 events7 affected198 at risk
Cardiac Arrhythmias - Cardiac arrest	Cardiac disorders	Systematic Assessment		EG0001 events1 affected203 at risk EG0010 events0 affected198 at risk
Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion	Cardiac disorders	Systematic Assessment		EG0002 events2 affected203 at risk EG0012 events2 affected198 at risk
Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio	Blood and lymphatic system disorders	Systematic Assessment		EG00056 events45 affected203 at risk EG00138 events30 affected198 at risk
Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring PPM	Cardiac disorders	Systematic Assessment		EG0005 events5 affected203 at risk EG00128 events28 affected198 at risk
Pericardial Fluid Collection	Cardiac disorders	Systematic Assessment		EG0003 events3 affected203 at risk EG0013 events3 affected198 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG00020 events16 affected203 at risk EG00110 events8 affected198 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0003 events3 affected203 at risk EG0015 events5 affected198 at risk
Hepatic Dysfunction	Hepatobiliary disorders	Systematic Assessment		EG0002 events2 affected203 at risk EG0010 events0 affected198 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment		EG00018 events15 affected203 at risk EG00116 events15 affected198 at risk
Major Infection - Endocarditis	Infections and infestations	Systematic Assessment		EG0001 events1 affected203 at risk EG0012 events2 affected198 at risk
Major Infection - Sepsis	Infections and infestations	Systematic Assessment		EG00012 events11 affected203 at risk EG0015 events5 affected198 at risk
Myocardial Infarction (Non- Procedure Related)	Cardiac disorders	Systematic Assessment		EG0002 events2 affected203 at risk EG0012 events2 affected198 at risk
Myocardial Infarction - Peri-CABG	Cardiac disorders	Systematic Assessment		EG0001 events1 affected203 at risk EG0010 events0 affected198 at risk
TIA	Vascular disorders	Systematic Assessment		EG0001 events1 affected203 at risk EG0012 events2 affected198 at risk
Ischemic Stroke	Vascular disorders	Systematic Assessment		EG0003 events3 affected203 at risk EG0019 events9 affected198 at risk
Hemorrhagic Stroke	Nervous system disorders	Systematic Assessment		EG0001 events1 affected203 at risk EG0011 events1 affected198 at risk
Toxic Metabolic Encephalopathy	Nervous system disorders	Systematic Assessment		EG0003 events3 affected203 at risk EG0014 events4 affected198 at risk
Seizure	Nervous system disorders	Systematic Assessment		EG0003 events2 affected203 at risk EG0013 events3 affected198 at risk
Renal Failure	Renal and urinary disorders	Systematic Assessment		EG0005 events5 affected203 at risk EG0013 events3 affected198 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0007 events5 affected203 at risk EG0017 events5 affected198 at risk
Heart Failure	Cardiac disorders	Systematic Assessment		EG00021 events13 affected203 at risk EG00114 events9 affected198 at risk
Arterial Non-CNS Thromboembolism	Vascular disorders	Systematic Assessment		EG0002 events2 affected203 at risk EG0010 events0 affected198 at risk
Venous Thromboembolic Event	Vascular disorders	Systematic Assessment		EG0002 events2 affected203 at risk EG0010 events0 affected198 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	Systematic Assessment		EG0000 events0 affected203 at risk EG0012 events2 affected198 at risk
Other SAE	General disorders	Systematic Assessment		EG00071 events47 affected203 at risk EG00152 events37 affected198 at risk
Neurological Dysfunction - Other	Nervous system disorders	Systematic Assessment	SAE term did not meet specific CTCAE event criteria	EG0001 events1 affected203 at risk EG0010 events0 affected198 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiac Arrhythmias -Sustained supraventricular arrhythmia requiring drug treatment or cardioversion	Cardiac disorders	Systematic Assessment	EG00062 events57 affected203 at risk EG00147 events44 affected198 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00013 events13 affected203 at risk EG0019 events9 affected198 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment	EG00021 events19 affected203 at risk EG00118 events15 affected198 at risk

ID	Term
D014262	Tricuspid Valve Insufficiency

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases