- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351984
Transcatheter Mitral Valvuloplasty Pilot Study (MitraClip)
February 14, 2022 updated by: Duk-Woo Park, MD
Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with severe mitral regurgitation
Description
Inclusion Criteria:
- Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
- Age 19 and more
- Written informed consent
Exclusion Criteria:
- Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
- Active endocarditis of the mitral valve
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe Mitral Regurgitation
|
Transcatheter Mitral Valvuloplasty with MitraClip
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mitral regurgitation
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial infarction
Time Frame: 1 year
|
1 year
|
|
Stroke
Time Frame: 1 year
|
1 year
|
|
All cause death
Time Frame: 1 year
|
1 year
|
|
Re-hospitalization
Time Frame: 1 year
|
1 year
|
|
Acute kidney dysfunction
Time Frame: 5 days
|
5 days
|
|
Vascular complication
Time Frame: 5 days
|
5 days
|
|
Bleeding
Time Frame: 5 days
|
5 days
|
|
Successful valvuloplasty
Time Frame: 5 days
|
No significant complication
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2020
Primary Completion (Actual)
December 16, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 17, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 14, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMCCV2020-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Mitral Regurgitation
-
Abbott Medical DevicesCompletedFunctional Mitral Regurgitation | Degenerrative Mitral RegurgitationRussian Federation
-
Ancora Heart, Inc.CompletedMitral Regurgitation | Mitral Valve Regurgitation | Functional Mitral RegurgitationAustria, Lithuania, Germany
-
Heinrich-Heine University, DuesseldorfCompletedMitral Regurgitation | Functional Mitral Regurgitation | Degenerative Mitral Valve RegurgitationGermany
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Mitre Medical Corp.BSWRI Cardiac Imaging Core Lab (CICL)Not yet recruitingIschemic Mitral Regurgitation | Functional Mitral RegurgitationUnited States
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Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
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Hospital Clinic of BarcelonaAbbottUnknownMITRAL REGURGITATIONSpain
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Boston Scientific CorporationActive, not recruitingCardiovascular Diseases | Mitral Regurgitation Functional | Mitral Valve DiseaseUnited States, Australia
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Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany
-
Mardil MedicalRecruitingFunctional Mitral RegurgitationCanada, Hungary, France, Germany, Netherlands, Panama, Poland
-
Shanghai Shenqi Medical Technology Co., LtdActive, not recruitingFunctional Mitral RegurgitationChina
Clinical Trials on MitraClip
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Abbott Medical DevicesActive, not recruitingHeart Failure | Mitral Regurgitation | Mitral Valve Regurgitation | Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure SubjectsUnited States, Canada
-
Population Health Research InstituteCompletedMitral RegurgitationCanada
-
Nantes University HospitalAbbott; Ministère de la SantéRecruiting
-
Abbott Medical DevicesAbbottTerminated
-
Azienda Socio Sanitaria Territoriale degli Spedali...RecruitingHeart Failure | Mitral RegurgitationItaly
-
Fundación Investigación Sanitaria en LeónAbbott Medical DevicesCompletedMitral Regurgitation | Acute Myocardial Infarction
-
Hospital Clinic of BarcelonaAbbottUnknownMITRAL REGURGITATIONSpain