Mitral Valve InsufficiencyMitraClipNCT04351984
Transcatheter Mitral Valvuloplasty Pilot Study
An observational study of Mitral Valve Insufficiency and Mitral Regurgitation, run by Duk-Woo Park, MD at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Regurgitation, Mitral Valve Regurgitation
- What is being tested?
- MitraClip
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe mitral regurgitation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- MitraClip
- Keywords
- MitraClip
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClipDevice
Also called Transcatheter Mitral Valvuloplasty
Transcatheter Mitral Valvuloplasty with MitraClip
| Study group | Role | What they receive |
|---|---|---|
| Severe Mitral Regurgitation | Not described Receives: Device: MitraClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral regurgitation
Measured: 1 month
Secondary outcomes (8)
All cause death
Measured: 1 year
Stroke
Measured: 1 year
Myocardial infarction
Measured: 1 year
Re-hospitalization
Measured: 1 year
Acute kidney dysfunction
Measured: 5 days
Vascular complication
Measured: 5 days
Bleeding
Measured: 5 days
Successful valvuloplasty
No significant complication
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 Oct 2020
- Primary completion16 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351984
- Sponsor's protocol ID
- AMCCV2020-04
- Acronym
- MitraClip
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study
- ClinicalTrials.gov ID
- NCT04351984
- Acronym / sponsor ID
- MitraClip / AMCCV2020-04
- Keywords
- MitraClip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Mitral Regurgitation | – | Device: MitraClip |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe mitral regurgitation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClipAlso: Transcatheter Mitral ValvuloplastyTranscatheter Mitral Valvuloplasty with MitraClip | Device | Severe Mitral Regurgitation |
Primary outcome
Mitral regurgitation
Time frame: 1 month
8 secondary outcomes
All cause death
Time frame: 1 year
Stroke
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Re-hospitalization
Time frame: 1 year
Acute kidney dysfunction
Time frame: 5 days
Vascular complication
Time frame: 5 days
Bleeding
Time frame: 5 days
Successful valvuloplasty
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency and Mitral Regurgitation, run by Duk-Woo Park, MD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitral regurgitation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.