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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Primary Purpose

Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TV Annuloplasty
MVS
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Tricuspid Regurgitation focused on measuring Tricuspid Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Stanford University School of Medicine
  • Yale University School of Medicine - Yale-New Haven Hospital
  • Emory University
  • University of Maryland
  • Suburban Hospital
  • MedStar Health
  • University of Michigan Health Services
  • Mayo Clinic
  • Dartmouth-Hitchcock Medical Center
  • Montefiore Einstein Heart Center
  • Columbia University Medical Center
  • Stony Brook Hospital
  • Mission Hospital
  • Duke University
  • WakeMed Clinical Research Institute
  • Cleveland Clinic
  • Ohio State University
  • University of Pennsylvania
  • Baylor College of Medicine
  • Baylor College of Medicine
  • Baylor Research Institute
  • University of Virginia Health Systems
  • University of Wisconsin
  • University of Alberta Hospital
  • London Health Sciences
  • University of Ottawa Heart Institute
  • Toronto General Hospital
  • Montreal Heart Institute
  • Centre Hospitalier de l'Université de Montréal
  • Hôpital du Sacré-Cœur de Montréal
  • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
  • Universitares Herzzentrum Hamburg
  • Herzzentrum Leipzig
  • University Hospital Frankfurt
  • University Medical Center Göttingen
  • University Medical Center Jena
  • HDZ NRW Bad Oeynhausen
  • Deutsches Herzzentrum Berlin
  • Heart Center, University of Freiburg
  • German Heart Center Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MVS Alone

MVS + TV Annuloplasty

Arm Description

Participants will undergo mitral valve surgery alone.

Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Diuretic Use
The diuretic requirements of patients will be assessed.
Six Minute Walk Test
The total distance, in feet, walked in six minutes
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.
Right Ventricular Size
Number of Participants With Normal RV Function
Number of Participants with Normal RV Function assessed by echocardiography.
Peak Tricuspid Annular Velocity
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Degree of RV function assessed by TAPSE
Right Ventricular Fractional Area Change (RVFAC)
Degree of RV function assessed by RVFAC
Pulmonary Artery Pressure
Pulmonary artery pressure assessed by echocardiography.
Right Ventricular Volume
RV Volume as measured by transthoracic 3D echocardiography.
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.
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.
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.
Survival
Incidence of participants alive
Length of Index Hospitalization
Number of Participants With Readmission
Incidence of readmissions
Number of Participants With TV Reoperations
Number of participants with TV reoperations
Economic Measures (Inpatient Costs)
Inpatient costs will be measured through the collection of hospital billing.
Number of Participants With Serious Adverse Events
Safety as measured by frequency of serious adverse events.
Gait Speed Test
Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks

Full Information

First Posted
January 29, 2016
Last Updated
September 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), German Society for Thoracic and Cardiovascular Surgery, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT02675244
Brief Title
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Official Title
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), German Society for Thoracic and Cardiovascular Surgery, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
Detailed Description
The tricuspid valve controls the flow of blood in your heart between the right ventricle and the right atrium. TR is a condition where the valve does not close fully when it is supposed to and blood can then leak back into the right atrium. When TR becomes severe, surgery is usually performed to correct it. The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. The available evidence addressing this issue is not definite: it is based on less rigorous methods of investigation, and the results have been conflicting. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about what surgical treatment is best for patients with your condition. This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
Keywords
Tricuspid Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVS Alone
Arm Type
Active Comparator
Arm Description
Participants will undergo mitral valve surgery alone.
Arm Title
MVS + TV Annuloplasty
Arm Type
Active Comparator
Arm Description
Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
Intervention Type
Procedure
Intervention Name(s)
TV Annuloplasty
Intervention Description
TV Annuloplasty will be performed using standard surgical techniques
Intervention Type
Procedure
Intervention Name(s)
MVS
Intervention Description
MVS will be performed using standard surgical techniques
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Failure
Description
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Description
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
Time Frame
up to 24 Months
Title
Number of Participants With NYHA Classification I-IV
Description
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
Time Frame
at 24 Months
Title
Diuretic Use
Description
The diuretic requirements of patients will be assessed.
Time Frame
24 Months
Title
Six Minute Walk Test
Description
The total distance, in feet, walked in six minutes
Time Frame
24 Months
Title
Number of Participants With Degree of TR
Description
Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.
Time Frame
up to 24 Months
Title
Right Ventricular Size
Time Frame
24 Months
Title
Number of Participants With Normal RV Function
Description
Number of Participants with Normal RV Function assessed by echocardiography.
Time Frame
up to 24 Months
Title
Peak Tricuspid Annular Velocity
Time Frame
24 Months
Title
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Description
Degree of RV function assessed by TAPSE
Time Frame
24 Months
Title
Right Ventricular Fractional Area Change (RVFAC)
Description
Degree of RV function assessed by RVFAC
Time Frame
24 Months
Title
Pulmonary Artery Pressure
Description
Pulmonary artery pressure assessed by echocardiography.
Time Frame
up to 24 Months
Title
Right Ventricular Volume
Description
RV Volume as measured by transthoracic 3D echocardiography.
Time Frame
24 Months
Title
SF-12
Description
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.
Time Frame
24 Months
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
24 Months
Title
EuroQoL (EQ-5D)
Description
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.
Time Frame
24 Months
Title
Survival
Description
Incidence of participants alive
Time Frame
up to 60 Months
Title
Length of Index Hospitalization
Time Frame
average 30 days
Title
Number of Participants With Readmission
Description
Incidence of readmissions
Time Frame
up to 24 months
Title
Number of Participants With TV Reoperations
Description
Number of participants with TV reoperations
Time Frame
up to 24 months
Title
Economic Measures (Inpatient Costs)
Description
Inpatient costs will be measured through the collection of hospital billing.
Time Frame
up to 60 months
Title
Number of Participants With Serious Adverse Events
Description
Safety as measured by frequency of serious adverse events.
Time Frame
24 months
Title
Gait Speed Test
Description
Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annetine C. Gelijns, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Weisel, MD
Organizational Affiliation
Toronto General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale University School of Medicine - Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8039
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
MedStar Health
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
University of Michigan Health Services
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Montefiore Einstein Heart Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
WakeMed Clinical Research Institute
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Hôpital du Sacré-Cœur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Universitares Herzzentrum Hamburg
City
Berlin
State/Province
Brandenburg
ZIP/Postal Code
11353
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Berlin
State/Province
Brandenburg
ZIP/Postal Code
13347
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt
State/Province
Hesse-Nassau
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Medical Center Göttingen
City
Göttingen
State/Province
Lower Saxony
Country
Germany
Facility Name
University Medical Center Jena
City
Jena
State/Province
Thuringia
Country
Germany
Facility Name
HDZ NRW Bad Oeynhausen
City
Bad Oeynhausen
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
Country
Germany
Facility Name
Heart Center, University of Freiburg
City
Freiburg
Country
Germany
Facility Name
German Heart Center Munich
City
Munich
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34767705
Citation
Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13.
Results Reference
derived

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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

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