MitraClip China PMS
Primary Purpose
Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MitraClip procedure
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation focused on measuring MR, Mitral Regurgitation, MitraClip
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Fuwai Hospital Chinese Academy of Medical SciencesRecruiting
- Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting
- Fuwai Hospital Chinese Academy of Medical Sciences, ShenzhenRecruiting
- Zhuhai People's Hospital
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Fuwai Yunnan Cardiovascular Hospital
- The 2nd Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MitraClip
Arm Description
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04259411
First Posted
September 23, 2019
Last Updated
October 13, 2023
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT04259411
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
MR, Mitral Regurgitation, MitraClip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MitraClip
Arm Type
Experimental
Arm Description
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
Intervention Type
Device
Intervention Name(s)
MitraClip procedure
Intervention Description
MitraClip procedure with MitraClip NTR System or MitraClip XTR System
Primary Outcome Measure Information:
Title
Rate of Acute Procedural Success (APS)
Description
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.
Time Frame
Discharge/30days
Title
Rate of freedom from Major Adverse Event (MAE)
Description
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.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Rate of all-cause mortality
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
Rate of freedom from the components of major adverse event (MAE)
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
New York Heart Association Functional Class
Description
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.
Time Frame
30 days, 1 year
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) scores
Description
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.
Time Frame
30 days, 1 year
Title
Six Minute Walk Test (6MWT) distance
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
Rate of mitral valve surgery (including type of surgery), including reason for intervention
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
Rate of additional MitraClip System intervention, including reason for intervention
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
Number of hospitalizations and reason for hospitalization (i.e. heart failure, cardiovascular, non-cardiovascular)
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
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
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
Rate of major bleeding
Description
Clinical Endpoints
Time Frame
30 days, 1 year
Title
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
Description
Device and Procedure-Related Endpoints
Time Frame
Day 0
Title
Device Procedure Time: Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed
Description
Device and Procedure-Related Endpoints
Time Frame
Day 0
Title
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
Description
Device and Procedure-Related Endpoints
Time Frame
Day 0
Title
Fluoroscopy Time: defined as the total minutes of exposure to fluoroscopy during the MitraClip procedure
Description
Device and Procedure-Related Endpoints
Time Frame
Day 0
Title
Length of stay in Intensive Care Unit/Critical Care Unit/Post-Anesthesia Care Unit (ICU/CCU/PACU)
Description
Device and Procedure-Related Endpoints
Time Frame
30 days
Title
Length of hospital stay for index MitraClip procedure
Description
Device and Procedure-Related Endpoints
Time Frame
30 days
Title
Mitral Regurgitation Severity Grade
Description
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.
Time Frame
30 days, 1 year
Title
Effective Regurgitant Orifice Area
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Regurgitant Volume (RV)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Regurgitant Fraction (RF)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Right Ventricular Systolic Pressure (RVSP)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Mitral Valve Area (MVA)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Systolic Anterior Motion of the mitral valve (present or absent)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Forward Stroke Volume (FSV)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Cardiac Output (CO)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
Title
Cardiac Index (CI)
Description
Echocardiographic Endpoints
Time Frame
30 days, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rio Zhan
Phone
+86-21-20335212
Email
wanlei.zhan@abbott.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Qin
Email
jenny.qin@abbott.com
Facility Information:
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lulu Han
Phone
+86-10-88398395
Email
lchyl_fuwai@sina.com
First Name & Middle Initial & Last Name & Degree
Shengshou Hu
Facility Name
Xiamen Cardiovascular Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoqing Lin
Phone
+86-592-2292562
Email
xxyllwyh@163.com
First Name & Middle Initial & Last Name & Degree
Yan Wang
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixiang Liu
Phone
+86-755-82180028
Email
szfwyykjb@126.com
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yali Li
Phone
+86-29-85323473
Email
xjyfyllh@163.com
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Withdrawn
Facility Name
The 2nd Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honggang Lou
Phone
+86-571-87783759
Email
HREC2013@126.com
First Name & Middle Initial & Last Name & Degree
Jian An Wang
12. IPD Sharing Statement
Plan to Share IPD
No
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MitraClip China PMS
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