Clinical trial NCT04259411: MitraClip China PMS
Official title: A Prospective, Multi-Center, Single-Arm, Post Market Study of the MitraClip System for the Treatment of Symptomatic Mitral Regurgitation in China
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: MR
Mitral Regurgitation
MitraClip
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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.)
2. Subject is 18 years-old or above.
3. Subjects who give consent for study procedure.

Exclusion Criteria:

1. Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.
2. Subject with active endocarditis of mitral valve.
3. Subject with rheumatic mitral valve disease.
4. Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus.
5. Subject is unlikely to survive the protocol follow up period of 12-months after device implant.
6. Subject has insufficient or lost ability to maintain their will and rights.
7. Subject is illiterate.
8. Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period
9. Subject participates in another clinical study that may impact the follow-up or results of this study.

Primary outcomes:
measure: Rate of Acute Procedural Success (APS)
timeFrame: Discharge/30days
measure: Rate of freedom from Major Adverse Event (MAE)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Rate of all-cause mortality
timeFrame: 30 days, 1 year
measure: Rate of freedom from the components of major adverse event (MAE)
timeFrame: 30 days, 1 year
measure: New York Heart Association Functional Class
timeFrame: 30 days, 1 year
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) scores
timeFrame: 30 days, 1 year
measure: Six Minute Walk Test (6MWT) distance
timeFrame: 30 days, 1 year
measure: Rate of mitral valve surgery (including type of surgery), including reason for intervention
timeFrame: 30 days, 1 year
measure: Rate of additional MitraClip System intervention, including reason for intervention
timeFrame: 30 days, 1 year
measure: Number of hospitalizations and reason for hospitalization (i.e. heart failure, cardiovascular, non-cardiovascular)
timeFrame: 30 days, 1 year
measure: Rate of device-related complications: defined as a composite of single leaflet device attachment (SLDA), device embolization, clinically significant iatrogenic septal defect or mitral stenosis that requires intervention
timeFrame: 30 days, 1 year
measure: Rate of major bleeding
timeFrame: 30 days, 1 year
measure: Total Procedure Time: defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE
timeFrame: Day 0
measure: Device Procedure Time: Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed
timeFrame: Day 0
measure: Device Time: Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter
timeFrame: Day 0
measure: Fluoroscopy Time: defined as the total minutes of exposure to fluoroscopy during the MitraClip procedure
timeFrame: Day 0
measure: Length of stay in Intensive Care Unit/Critical Care Unit/Post-Anesthesia Care Unit (ICU/CCU/PACU)
timeFrame: 30 days
measure: Length of hospital stay for index MitraClip procedure
timeFrame: 30 days
measure: Mitral Regurgitation Severity Grade
timeFrame: 30 days, 1 year
measure: Effective Regurgitant Orifice Area
timeFrame: 30 days, 1 year
measure: Regurgitant Volume (RV)
timeFrame: 30 days, 1 year
measure: Regurgitant Fraction (RF)
timeFrame: 30 days, 1 year
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 30 days, 1 year
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 30 days, 1 year
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 30 days, 1 year
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 30 days, 1 year
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 30 days, 1 year
measure: Right Ventricular Systolic Pressure (RVSP)
timeFrame: 30 days, 1 year
measure: Mitral Valve Area (MVA)
timeFrame: 30 days, 1 year
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 30 days, 1 year
measure: Systolic Anterior Motion of the mitral valve (present or absent)
timeFrame: 30 days, 1 year
measure: Forward Stroke Volume (FSV)
timeFrame: 30 days, 1 year
measure: Cardiac Output (CO)
timeFrame: 30 days, 1 year
measure: Cardiac Index (CI)
timeFrame: 30 days, 1 year
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Shenzhen
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
state: Guangdong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: