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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

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.

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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.

City, postcode or hospital

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

Other trials in China

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 groups in NCT04259411
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.

6 Dec 20217 Mar 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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