Back to resultsComparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Primary Purpose
Mitral Valve Insufficiency, Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mitral Valve Repair with Annuloplasty
Mitral Valve Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Ischemic Mitral Regurgitation, Mitral Valve Disease, Severe Mitral Regurgitation
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
Sites / Locations
- University of Southern California
- Emory University
- Wellstar Kennestone Hospital
- University of Maryland
- NIH Heart Center at Suburban Hospital
- Brigham and Women's Hospital
- Washington University
- Montefiore Einstein Heart Center
- Columbia University Medical Center
- Mission Hospital
- Duke University
- East Carolina Heart Institute
- Cleveland Clinic Foundation
- Ohio State University
- University of Pennsylvania
- Baylor Research Institute
- University of Virginia
- Inova Heart and Vascular Institute
- Montreal Heart Institute
- Hôpital du Sacré-Coeur de Montréal
- Quebec Heart Institute/Laval Hopital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mitral Valve Repair with Annuloplasty
Mitral Valve Replacement
Arm Description
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Outcomes
Primary Outcome Measures
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Secondary Outcome Measures
All-cause Mortality
Full Information
NCT ID
NCT00807040
First Posted
December 10, 2008
Last Updated
February 28, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00807040
Brief Title
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Official Title
Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
March 2014 (Actual)
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), National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve. The best way to fix the mitral valve remains undetermined. This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Coronary Artery Disease
Keywords
Ischemic Mitral Regurgitation, Mitral Valve Disease, Severe Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitral Valve Repair with Annuloplasty
Arm Type
Active Comparator
Arm Description
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Arm Title
Mitral Valve Replacement
Arm Type
Active Comparator
Arm Description
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
Intervention Type
Procedure
Intervention Name(s)
Mitral Valve Repair with Annuloplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mitral Valve Replacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
Measured at Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Gardner, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick O'Gara, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annetine C. Gelijns, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30383
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
NIH Heart Center at Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
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
East Carolina Heart Institute
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cleveland Clinic Foundation
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 Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
QC H4J 1C5
Country
Canada
Facility Name
Quebec Heart Institute/Laval Hopital
City
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24245543
Citation
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.
Results Reference
result
PubMed Identifier
33573741
Citation
Bertrand PB, Overbey JR, Zeng X, Levine RA, Ailawadi G, Acker MA, Smith PK, Thourani VH, Bagiella E, Miller MA, Gupta L, Mack MJ, Gillinov AM, Giustino G, Moskowitz AJ, Gelijns AC, Bowdish ME, O'Gara PT, Gammie JS, Hung J; Cardiothoracic Surgical Trials Network (CTSN). Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation. J Am Coll Cardiol. 2021 Feb 16;77(6):713-724. doi: 10.1016/j.jacc.2020.11.066.
Results Reference
derived
PubMed Identifier
31146872
Citation
Giustino G, Overbey J, Taylor D, Ailawadi G, Kirkwood K, DeRose J, Gillinov MA, Dagenais F, Mayer ML, Moskowitz A, Bagiella E, Miller M, Grayburn P, Smith PK, Gelijns A, O'Gara P, Acker M, Lala A, Hung J. Sex-Based Differences in Outcomes After Mitral Valve Surgery for Severe Ischemic Mitral Regurgitation: From the Cardiothoracic Surgical Trials Network. JACC Heart Fail. 2019 Jun;7(6):481-490. doi: 10.1016/j.jchf.2019.03.001.
Results Reference
derived
PubMed Identifier
30785252
Citation
Ferket BS, Ailawadi G, Gelijns AC, Acker M, Hohmann SF, Chang HL, Bouchard, D, Meltzer DO, Michler RE, Moquete EG, Voisine P, Mullen JC, Lala A, Mack MJ, Gillinov AM, Thourani VH, Miller MA, Gammie JS, Parides MK, Bagiella E, Smith RL, Smith PK, Hung JW, Gupta LN, Rose EA, O'Gara PT, Moskowitz AJ, Cardiothoracic Surgical Trials Network (CTSN) Investigators. Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the Cardiothoracic Surgical Trials Network. Circ Cardiovasc Qual Outcomes. 2018 Nov 14;11(11):e004466. doi: 10.1161/CIRCOUTCOMES.117.004466.
Results Reference
derived
PubMed Identifier
27777294
Citation
Capoulade R, Zeng X, Overbey JR, Ailawadi G, Alexander JH, Ascheim D, Bowdish M, Gelijns AC, Grayburn P, Kron IL, Levine RA, Mack MJ, Melnitchouk S, Michler RE, Mullen JC, O'Gara P, Parides MK, Smith P, Voisine P, Hung J; Cardiothoracic Surgical Trials Network (CTSN) Investigators. Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation. 2016 Oct 25;134(17):1247-1256. doi: 10.1161/CIRCULATIONAHA.115.021014.
Results Reference
derived
PubMed Identifier
26550689
Citation
Goldstein D, Moskowitz AJ, Gelijns AC, Ailawadi G, Parides MK, Perrault LP, Hung JW, Voisine P, Dagenais F, Gillinov AM, Thourani V, Argenziano M, Gammie JS, Mack M, Demers P, Atluri P, Rose EA, O'Sullivan K, Williams DL, Bagiella E, Michler RE, Weisel RD, Miller MA, Geller NL, Taddei-Peters WC, Smith PK, Moquete E, Overbey JR, Kron IL, O'Gara PT, Acker MA; CTSN. Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation. N Engl J Med. 2016 Jan 28;374(4):344-53. doi: 10.1056/NEJMoa1512913. Epub 2015 Nov 9.
Results Reference
derived
PubMed Identifier
25500293
Citation
Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6.
Results Reference
derived
Links:
URL
http://www.ctsurgerynet.org/
Description
Click here for the Cardiothoracic Surgical Trials Network Web site.
Learn more about this trial
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
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