- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01406353
Early Percutaneous Mitral Intervention in Asymptomatic Moderate Mitral Stenosis (MITIGATE)
Early Percutaneous Mitral Intervention Versus Conventional Management in Asymptomatic Moderate Mitral Stenosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We enroll consecutive asymptomatic patients with moderate mitral stenosis who are candidates for both early percutaneous mitral commissurotomy (PMC) and conventional treatment at 3 centers in Seoul, Korea.
Echocardiographic evaluation is performed before enrollment, immediately after PMC and annually during follow-up. All patients undergo two-dimensional echocardiography and/or transesophageal echocardiography to detect left atrial thrombi. Morphologic features of the mitral valve (MV) are categorized as described previously (14), and total echocardiographic score is obtained by adding the scores for leaflet mobility, thickness, calcification, and subvalvular lesions. The MVA is measured by direct planimetry of the mitral orifice, and MS severity is graded as mild, moderate, or severe when MVA was > 1.5, 1.0 to 1.5, or < 1.0 cm2, respectively. The severity of mitral and tricuspid regurgitation is assessed semiquantitatively or using quantitative methods and classified as mild, moderate, or severe. Pulmonary artery systolic pressure (PAP) is estimated by continuous wave Doppler with the simplified Bernoulli equation.
All study patients regularly visit their attending physicians at 3 monthly interval for maintenance of anticoagulation therapy or every year for annual re-evaluation. Patients in the conventional treatment group who become symptomatic during follow-up are referred for PMC or mitral valve surgery. An embolic event is defined as a systemic embolism fulfilling both prespecified criteria: acute onset of clinical symptoms or signs of embolism and occurrence of new lesions confirmed by imaging studies. A specific diagnosis of cerebral infarction is confirmed by an experienced neurologist and additional brain magnetic resonance imaging is performed if indicated.
We estimate that a sample size of 166 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming 3-year event rates of 13% in the conventional treatment group and 2% in the early PMC group, and drop-out rate of 5%. These rates are based on the results of our previous study. Analyses are performed on an intention-to-treat basis. To analyze primary outcome, estimates of cumulative event rates are calculated by the Kaplan-Meier method and compared employing the log-rank test. For Kaplan-Meier analysis, we analyze all clinical events by time to first event. Hazard ratios with 95% confidence intervals are derived with the use of the Cox proportional hazards model.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
Seoul, Korea, Republic of
- Yonsei University Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- asymptomatic patients with moderate MS who are potential candidates for early percutaneous mitral commissurotomy
Exclusion Criteria:
- patients with exertional dyspnea
- total echocardiographic score > 10
- moderate to severe mitral regurgitation
- left atrial thrombi
- significant aortic valve disease,
- left ventricle (LV) ejection fraction (EF) <50%
- Doppler-estimated pulmonary artery systolic pressure >50 mmHg
- those who were not candidates for early intervention based on age > 70 years or the presence of coexisting malignancies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early Percutaneous Mitral Intervention
early elective percutaneous mitral commissurotomy within 3 months of enrollment
|
Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon technique.
During the procedure, conventional hemodynamic parameters are monitored.
A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.
Other Names:
|
No Intervention: Conventional Treatment
All patients in the conventional treatment group regularly visit their attending physicians at 3 monthly interval for maintenance of anticoagulation therapy or every year for annual re-evaluation.
Patients who become symptomatic during follow-up are referred for percutaneous mitral commissurotomy or mitral valve surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of cardiovascular event
Time Frame: Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
Composite of cardiovascular mortality, cerebral infarction, systemic embolic events that occurred during follow-up, and PMC-related complications; procedural mortality and urgent MV surgery.
|
Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause death and each component of cardiovascular event
Time Frame: Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
all-cause death and any component of composite primary end point.
|
Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
Mitral valve replacement
Time Frame: Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
Participants will be followed for the duration of the trial, a minimum follow-up of 3 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kang DH, Lee CH, Kim DH, Yun SC, Song JM, Lee CW, Song JK, Park SW, Park SJ. Early percutaneous mitral commissurotomy vs. conventional management in asymptomatic moderate mitral stenosis. Eur Heart J. 2012 Jun;33(12):1511-7. doi: 10.1093/eurheartj/ehr495. Epub 2012 Jan 13.
- Kang DH, Park SJ, Lee SA, Lee S, Kim DH, Park DW, Yun SC, Hong GR, Song JM, Hong MK, Park SW, Park SJ. Early percutaneous mitral commissurotomy or conventional management for asymptomatic mitral stenosis: a randomised clinical trial. Heart. 2021 Dec;107(24):1980-1986. doi: 10.1136/heartjnl-2021-319857. Epub 2021 Sep 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-0432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate Mitral Stenosis
-
Insel Gruppe AG, University Hospital BernRecruitingAortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral RegurgitationSwitzerland
-
Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
-
Medical University of WarsawInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Medical... and other collaboratorsRecruitingHeart Failure | Mitral Insufficiency | Mitral Stenosis | Mitral Stenosis With Insufficiency | Bioprosthesis FailurePoland
-
Xiamen Cardiovascular Hospital, Xiamen UniversityRecruitingHeart Failure | Mitral Regurgitation | Mitral Stenosis | Mitral Stenosis With Insufficiency | Bioprosthesis FailureChina
-
Foldax, IncActive, not recruitingMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Disease | Mitral StenosisIndia
-
Edwards LifesciencesNot yet recruitingMitral Regurgitation | Mitral Valve Disease | Mitral Stenosis
-
Federal University of BahiaCompletedMitral Insufficiency | Mitral StenosisBrazil
-
University of AarhusUnknown
-
Edwards LifesciencesRecruitingMitral Valve Insufficiency | Mitral StenosisUnited States, Canada
-
Konkuk University Medical CenterCompletedMitral Regurgitation | Tricuspid Regurgitation | Mitral StenosisKorea, Republic of
Clinical Trials on Percutaneous Mitral Commissurotomy
-
Assiut UniversityUnknownPulmonary Hypertension
-
Helse Stavanger HFHaukeland University HospitalNot yet recruitingRheumatic Heart DiseaseEthiopia
-
ViacorDuke University; Medifacts International CorporationSuspendedHeart Failure | Mitral RegurgitationBelgium, Czech Republic, Germany, Netherlands, Switzerland
-
ViacorCompletedHeart Failure | Mitral RegurgitationCanada
-
MyocorUnknownHeart Failure | Ischemic Heart Disease | Mitral Valve Regurgitation | Mitral Insufficiency | Left Ventricular Dysfunction | Mitral IncompetenceUnited States
-
ViacorCompletedHeart Failure | Mitral RegurgitationGermany
-
Maastricht University Medical CenterCompletedVentricular Septal Rupture | Papillary Muscle Rupture | Free Wall Rupture, HeartNetherlands
-
Cardiac Dimensions, Inc.RecruitingHeart Diseases | Cardiovascular Diseases | Heart Failure | Heart Valve Diseases | Mitral Valve Insufficiency | Functional Mitral RegurgitationUnited States, Greece, France, Poland
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Abbott Medical DevicesCompletedMitral Valve ProlapseUnited Kingdom