Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
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| ClinicalTrials.gov Identifier: NCT00807040 |
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Recruitment Status :
Completed
First Posted : December 11, 2008
Results First Posted : July 31, 2017
Last Update Posted : March 15, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mitral Valve Insufficiency Coronary Artery Disease | Procedure: Mitral Valve Repair with Annuloplasty Procedure: Mitral Valve Replacement | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 251 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | March 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Mitral Valve Repair with Annuloplasty
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
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Procedure: 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. |
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Active Comparator: Mitral Valve Replacement
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
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Procedure: 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. |
- Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Measured at Month 12 ]
- All-cause Mortality [ Time Frame: Measured at Month 24 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807040
Show 21 study locations
| Study Chair: | Timothy Gardner, MD | Christiana Care Health Services | |
| Study Chair: | Patrick O'Gara, MD | Brigham and Women's Hospital | |
| Principal Investigator: | Annetine C. Gelijns, Ph.D. | Icahn School of Medicine at Mount Sinai |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alan Moskowitz, Professor, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT00807040 |
| Obsolete Identifiers: | NCT00919256 |
| Other Study ID Numbers: |
GCO 08-1078-00002 U01HL088942 ( U.S. NIH Grant/Contract ) U01 HL088942-01-2 595 ( Other Identifier: Ct Surgery Network Research Group ) |
| First Posted: | December 11, 2008 Key Record Dates |
| Results First Posted: | July 31, 2017 |
| Last Update Posted: | March 15, 2019 |
| Last Verified: | February 2019 |
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Ischemic Mitral Regurgitation Mitral Valve Disease Severe Mitral Regurgitation |
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Coronary Artery Disease Mitral Valve Insufficiency Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Valve Diseases |