Mitral RegurgitationNCT04259411
MitraClip China PMS
A study testing MitraClip procedure in people with Mitral Regurgitation, run by Abbott Medical Devices at 5 sites in China.
Trial summary
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for open-heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitraClip procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesChina
- Study dates
- 6 Dec 2021to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.)
- Subject is 18 years-old or above.
- Subjects who give consent for study procedure.
Who cannot join
- Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.
- Subject with active endocarditis of mitral valve.
- Subject with rheumatic mitral valve disease.
- Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus.
- Subject is unlikely to survive the protocol follow up period of 12-months after device implant.
- Subject has insufficient or lost ability to maintain their will and rights.
Show all 9Show fewer
- Subject is illiterate.
- Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period
- Subject participates in another clinical study that may impact the follow-up or results of this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The 2nd Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361008
About this study
Official title: A Prospective, Multi-Center, Single-Arm, Post Market Study of the MitraClip System for the Treatment of Symptomatic Mitral Regurgitation in China
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days.
Read the detailed description
Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs when the mitral valve does not close properly, allowing blood to leak back into the upper chamber of the heart. As a result, the heart may try to pump harder in order to compensate for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and fatigue. These patients are at risk of poor quality of life, marked limitation in activity, repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often associated with heart failure and can lead to death if left untreated.
While mitral valve repair or replacement surgery is currently regarded as standard of care, many patients with clinically significant MR are at an unacceptable risk of morbidity and mortality and are therefore not appropriate surgical candidates. To optimize afterload reduction and treatment of fluid load, these patients are often treated with medical management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may relieve MR symptoms, but does not address the underlying cause of the condition. As a result, a significant portion of patients treated medically continue to progress to heart failure and experience an increasingly debilitating quality of life. A significant unmet clinical need thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk patients.
The MitraClip System has been in clinical use for treatment of significant MR since 2003. The MitraClip System received CE (Conformité Européenne) Mark for both DMR and FMR indications in March 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication in March 2019. The system is approved for use in more than 102 countries or regions worldwide. More than 100,000 patients have undergone the MitraClip procedure worldwide. On June 15, 2020, the MitraClip System has been approved for clinical use in China.
- Conditions
- Mitral Regurgitation
- Being tested
- MitraClip procedure
- Keywords
- MR, Mitral Regurgitation, 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.
MitraClip procedureDevice
MitraClip procedure with MitraClip NTR System or MitraClip XTR System
| Study group | Role | What they receive |
|---|---|---|
| MitraClip | Experimental | Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System. Receives: Device: MitraClip procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Acute Procedural Success (APS)
APS is defined as successful implantation of the MitraClip device(s) with resulting MR severity of 2+ or less as determined by the ECL assessment of a discharge echocardiogram (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable).
Measured: Discharge/30days
Percentage of Participants With Freedom From Major Adverse Event (MAE)
A Major Adverse Event (MAE) was determined as the composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device- or procedure-related adverse events occurring after the femoral vein puncture for transseptal access.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start6 Dec 2021
- Primary completion29 May 2024
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle J Brunner, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259411
- Sponsor's protocol ID
- ABT-CIP-10263
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2019
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm, Post Market Study of the MitraClip System for the Treatment of Symptomatic Mitral Regurgitation in China
- ClinicalTrials.gov ID
- NCT04259411
- Acronym / sponsor ID
- ABT-CIP-10263
- Conditions
- Mitral Regurgitation
- Keywords
- MR, Mitral Regurgitation, MitraClip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days.
Detailed description
Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs when the mitral valve does not close properly, allowing blood to leak back into the upper chamber of the heart. As a result, the heart may try to pump harder in order to compensate for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and fatigue. These patients are at risk of poor quality of life, marked limitation in activity, repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often associated with heart failure and can lead to death if left untreated.
While mitral valve repair or replacement surgery is currently regarded as standard of care, many patients with clinically significant MR are at an unacceptable risk of morbidity and mortality and are therefore not appropriate surgical candidates. To optimize afterload reduction and treatment of fluid load, these patients are often treated with medical management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may relieve MR symptoms, but does not address the underlying cause of the condition. As a result, a significant portion of patients treated medically continue to progress to heart failure and experience an increasingly debilitating quality of life. A significant unmet clinical need thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk patients.
The MitraClip System has been in clinical use for treatment of significant MR since 2003. The MitraClip System received CE (Conformité Européenne) Mark for both DMR and FMR indications in March 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication in March 2019. The system is approved for use in more than 102 countries or regions worldwide. More than 100,000 patients have undergone the MitraClip procedure worldwide. On June 15, 2020, the MitraClip System has been approved for clinical use in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip | Experimental | Device: MitraClip procedureSubject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.)
- Subject is 18 years-old or above.
- Subjects who give consent for study procedure.
Key exclusion criteria (9 listed)
- Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.
- Subject with active endocarditis of mitral valve.
- Subject with rheumatic mitral valve disease.
- Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus.
- Subject is unlikely to survive the protocol follow up period of 12-months after device implant.
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 |
|---|---|---|
| MitraClip procedureMitraClip procedure with MitraClip NTR System or MitraClip XTR System | Device | MitraClip |
Primary outcome
Percentage of Participants With Acute Procedural Success (APS)
Time frame: Discharge/30days
APS is defined as successful implantation of the MitraClip device(s) with resulting MR severity of 2+ or less as determined by the ECL assessment of a discharge echocardiogram (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable).
Percentage of Participants With Freedom From Major Adverse Event (MAE)
Time frame: 30 days
A Major Adverse Event (MAE) was determined as the composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device- or procedure-related adverse events occurring after the femoral vein puncture for transseptal access.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
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A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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The PALMETTO Study
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Edge-to-edge Mitral Valve Repair in ATTR-CM
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The ENCIRCLE Trial
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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.
Kyle J Brunner study director
Abbott Structural Heart
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraClip procedure in people with Mitral Regurgitation, run by Abbott Medical Devices at 5 sites in China.
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 9 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Acute Procedural Success (APS) (time frame: Discharge/30days). The study lists 2 primary outcomes in all. 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 15 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.