MitraClip China PMS

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitraClip procedure

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rio Zhan; Phone Number: +86-21-20335212; Email: wanlei.zhan@abbott.com
• Study Contact Backup: Name: Jenny Qin; Email: jenny.qin@abbott.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital Chinese Academy of Medical Sciences
      • Contact: Lulu Han; Phone Number: +86-10-88398395; Email: lchyl_fuwai@sina.com
      • Principal Investigator: Shengshou Hu
  • Fujian
    • Xiamen, Fujian, China, 361008
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University
      • Contact: Shaoqing Lin; Phone Number: +86-592-2292562; Email: xxyllwyh@163.com
      • Principal Investigator: Yan Wang
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
      • Contact: Lixiang Liu; Phone Number: +86-755-82180028; Email: szfwyykjb@126.com
      • Principal Investigator: Xiangbin Pan
    • Zhuhai, Guangdong, China
      • Withdrawn
      • Zhuhai People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Yali Li; Phone Number: +86-29-85323473; Email: xjyfyllh@163.com
      • Principal Investigator: Zuyi Yuan
  • Yunnan
    • Kunming, Yunnan, China
      • Withdrawn
      • Fuwai Yunnan Cardiovascular Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The 2nd Affiliated Hospital of Zhejiang University
      • Contact: Honggang Lou; Phone Number: +86-571-87783759; Email: HREC2013@126.com
      • Principal Investigator: Jian An Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MitraClip; Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.	Device: MitraClip procedure; MitraClip procedure with MitraClip NTR System or MitraClip XTR System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of 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). Patients who die or who undergo mitral valve surgery before discharge are an APS failure.	Discharge/30days
Rate of freedom from Major Adverse Event (MAE)	MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause mortality	Clinical Endpoints	30 days, 1 year
Rate of freedom from the components of major adverse event (MAE)	Clinical Endpoints	30 days, 1 year
New York Heart Association Functional Class	Clinical Endpoints. New York Heart Association (NYHA) Functional Class provides a scale of extent of heart failure. It has 4 categories of how much limitations of physical activities and heart failure symptoms and is presented as Class I, Class II, Class III and Class IV. Higher class represent a worse outcome.	30 days, 1 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) scores	Clinical Endpoints. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	30 days, 1 year
Six Minute Walk Test (6MWT) distance	Clinical Endpoints	30 days, 1 year
Rate of mitral valve surgery (including type of surgery), including reason for intervention	Clinical Endpoints	30 days, 1 year
Rate of additional MitraClip System intervention, including reason for intervention	Clinical Endpoints	30 days, 1 year
Number of hospitalizations and reason for hospitalization (i.e. heart failure, cardiovascular, non-cardiovascular)	Clinical Endpoints	30 days, 1 year
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	Clinical Endpoints	30 days, 1 year
Rate of major bleeding	Clinical Endpoints	30 days, 1 year
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	Device and Procedure-Related Endpoints	Day 0
Device Procedure Time: Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed	Device and Procedure-Related Endpoints	Day 0
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	Device and Procedure-Related Endpoints	Day 0
Fluoroscopy Time: defined as the total minutes of exposure to fluoroscopy during the MitraClip procedure	Device and Procedure-Related Endpoints	Day 0
Length of stay in Intensive Care Unit/Critical Care Unit/Post-Anesthesia Care Unit (ICU/CCU/PACU)	Device and Procedure-Related Endpoints	30 days
Length of hospital stay for index MitraClip procedure	Device and Procedure-Related Endpoints	30 days
Mitral Regurgitation Severity Grade	Echocardiographic Endpoints. Mitral regurgitation (MR) severity is measured by echocardiography. The severity is categorized in 4 grades and presented in 1+, 2+, 3+ and 4+. Higher grade represent a worse outcome.	30 days, 1 year
Effective Regurgitant Orifice Area	Echocardiographic Endpoints	30 days, 1 year
Regurgitant Volume (RV)	Echocardiographic Endpoints	30 days, 1 year
Regurgitant Fraction (RF)	Echocardiographic Endpoints	30 days, 1 year
Left Ventricular End Diastolic Volume (LVEDV)	Echocardiographic Endpoints	30 days, 1 year
Left Ventricular End Systolic Volume (LVESV)	Echocardiographic Endpoints	30 days, 1 year
Left Ventricular End Diastolic Dimension (LVEDD)	Echocardiographic Endpoints	30 days, 1 year
Left Ventricular End Systolic Dimension (LVESD)	Echocardiographic Endpoints	30 days, 1 year
Left Ventricular Ejection Fraction (LVEF)	Echocardiographic Endpoints	30 days, 1 year
Right Ventricular Systolic Pressure (RVSP)	Echocardiographic Endpoints	30 days, 1 year
Mitral Valve Area (MVA)	Echocardiographic Endpoints	30 days, 1 year
Mean Mitral Valve Pressure Gradient (MVG)	Echocardiographic Endpoints	30 days, 1 year
Systolic Anterior Motion of the mitral valve (present or absent)	Echocardiographic Endpoints	30 days, 1 year
Forward Stroke Volume (FSV)	Echocardiographic Endpoints	30 days, 1 year
Cardiac Output (CO)	Echocardiographic Endpoints	30 days, 1 year
Cardiac Index (CI)	Echocardiographic Endpoints	30 days, 1 year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mitral Regurgitation; MitraClip; MR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CRD956-PMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes