Functional Mitral RegurgitationNCT02471664
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
A study testing Mitral Loop Cerclage Annuloplasty in people with Functional Mitral Regurgitation and Heart Failure, run by Tau-MEDICAL Co., Ltd. at 2 sites in 2 countries.
Trial summary
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Functional Mitral Regurgitation, Heart Failure
- What is being tested?
- Mitral Loop Cerclage Annuloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment.
- (For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)
Who cannot join
- Primary Mitral Regurgitation
- LV ejection fraction lower than 25%
- Creatinine ≥2.0 mg/dL
- Anomaly of Coronary Sinus
- Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
- 2:1 Atriventricular AV block or higher AV block and ventricular tachycardia
Show all 18Show fewer
- Subjects with functional MR who need CABG or AVR performed
- Subjects who have functional MR caused by aortic valve disease
- Subjects who have uncontrollable hyperthyroidism
- Subjects who have severe TR due to primary valve leaflet disease
- Subjects who cannot be screened by cardiac CT
- Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT
- Subjects who are unable to take anti-platelet agents
- Subjects who are participated in other clinical trials within 1 month of enrollment
- Subjects who have coagulation disorders
- Subjects who have thrombosis and embolism
- Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
- Subjects who are deemed not to be eligible in this study by physician's discretion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Institues of Health
Bethesda, Maryland, 20892
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
About this study
Official title: The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
Read the detailed description
The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.
- Conditions
- Functional Mitral Regurgitation, Heart Failure
- Being tested
- Mitral Loop Cerclage Annuloplasty
- Keywords
- Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Loop Cerclage AnnuloplastyDevice
Also called MLC series (MLC-B-45-75-R and other 11 models)
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device Receives: Device: Mitral Loop Cerclage Annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Measured: 1 month
Change in mitral annulus geometry (septal lateral dimension)
Measured: 1 month
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event)
- Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Measured: 1 month
Secondary outcomes (7)
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Measured: 6 months
Change in mitral annulus geometry (septal lateral dimension)
Measured: 6 months
Change in mitral valve hemodynamics
Measured: 6 months
Change in left ventricle volumes
Measured: 6 months
Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
Measured: 6 months
Technical success rate of the implantation and technical feasibility
Measured: 6 months
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event)
- Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Mitral RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tau-MEDICAL Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital
- Investigators
- June-Hong Kim, MD, Ph D, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471664
- Sponsor's protocol ID
- TPMMLC
- Status last verified
- Oct 2017
- First submitted
- 5 Jun 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JH, Kocaturk O, Ozturk C, Faranesh AZ, Sonmez M, Sampath S, Saikus CE, Kim AH, Raman VK, Derbyshire JA, Schenke WH, Wright VJ, Berry C, McVeigh ER, Lederman RJ. Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: initial results in swine. J Am Coll Cardiol. 2009 Aug 11;54(7):638-51. doi: 10.1016/j.jacc.2009.03.071.
PubMed 19660696Park YH, Chon MK, Lederman RJ, Sung SC, Je HG, Choo KS, Lee SH, Shin ES, Kim JS, Hwang KW, Lee SY, Chun KJ, Kim CM, Kim JH. Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results. JACC Cardiovasc Interv. 2017 Mar 27;10(6):597-610. doi: 10.1016/j.jcin.2016.12.282.
PubMed 28335897
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test
- ClinicalTrials.gov ID
- NCT02471664
- Acronym / sponsor ID
- TPMMLC
- Conditions
- Functional Mitral Regurgitation, Heart Failure
- Keywords
- Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tau-MEDICAL Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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.
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
Detailed description
The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Device: Mitral Loop Cerclage AnnuloplastyIntervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment.
- (For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)
Key exclusion criteria (18 listed)
- Primary Mitral Regurgitation
- LV ejection fraction lower than 25%
- Creatinine ≥2.0 mg/dL
- Anomaly of Coronary Sinus
- Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
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 |
|---|---|---|
| Mitral Loop Cerclage AnnuloplastyAlso: MLC series (MLC-B-45-75-R and other 11 models) | Device | Single |
Primary outcome
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time frame: 1 month
Change in mitral annulus geometry (septal lateral dimension)
Time frame: 1 month
Rate of adverse events as a measure of safety
Time frame: 1 month
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
7 secondary outcomes
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time frame: 6 months
Change in mitral annulus geometry (septal lateral dimension)
Time frame: 6 months
Change in mitral valve hemodynamics
Time frame: 6 months
Change in left ventricle volumes
Time frame: 6 months
Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
Time frame: 6 months
Technical success rate of the implantation and technical feasibility
Time frame: 6 months
Rate of adverse events as a measure of safety
Time frame: 6 months
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 13 Oct 2017.
- Background: PubMed 19660696Kim JH, Kocaturk O, Ozturk C, Faranesh AZ, Sonmez M, Sampath S, Saikus CE, Kim AH, Raman VK, Derbyshire JA, Schenke WH, Wright VJ, Berry C, McVeigh ER, Lederman RJ. Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: initial results in swine. J Am Coll Cardiol. 2009 Aug 11;54(7):638-51. doi: 10.1016/j.jacc.2009.03.071.
- Results publication: PubMed 28335897Park YH, Chon MK, Lederman RJ, Sung SC, Je HG, Choo KS, Lee SH, Shin ES, Kim JS, Hwang KW, Lee SY, Chun KJ, Kim CM, Kim JH. Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results. JACC Cardiovasc Interv. 2017 Mar 27;10(6):597-610. doi: 10.1016/j.jcin.2016.12.282.
Related trials for Functional Mitral Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Recruiting
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Functional Mitral Regurgitation
Recruiting
Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome
Transcranial Direct Current Stimulation, Post-Concussion Syndrome
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.
June-Hong Kim, MD, Ph D principal investigator
Pusan National University Yangsan Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Loop Cerclage Annuloplasty in people with Functional Mitral Regurgitation and Heart Failure, run by Tau-MEDICAL Co., Ltd. at 2 sites in 2 countries.
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 2 inclusion and 18 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO) (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471664, which also lists 2 linked publications.
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 13 Oct 2017.