Status:
TERMINATED
PARACHUTE China Approval Trial
Lead Sponsor:
CardioKinetix, Inc
Collaborating Sponsors:
Guangzhou Chuangsi Medical Technology Co., Ltd.
Peking University
Conditions:
Ischemic Heart Failure
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system. The purpose of ...
Detailed Description
CardioKinetix has developed a catheter-based treatment method that can be used for treating patients with heart failure due to ischemic heart disease (left ventricle enlargement after anterior wall my...
Eligibility Criteria
Inclusion
- Age ≥ 18 years ≤ 79 years
- BMI \< 40'
- Left ventricle ejection fraction ≤40% and ≥15%
- Previous transthoracic echocardiography showing LV MI structural heart dysfunction represented by LV wall motion abnormalities (WMA)
- Appearance of ischemic heart failure symptoms (NYHA class II to "nonhospitalized" class IV) following anterior wall infarction and within the previous 60 days
- Left ventricle must have the appropriate anatomical structures (size and shape); cardiac CT and left ventricular angiography are used to confirm that implanting an appropriate Parachute device is possible
- Have received appropriate treatment according to ACC/AHA guidelines
- Subject or his/her legal representative informed of the nature of the study and consented to participate in all the provisions of the trial, signed the EC-approved informed consent form, agreed to undergo the post-surgery treatment plan and follow-up requirements, and is able to complete the follow-up and required follow-up examinations.
Exclusion
- Significant ventricle wall motion abnormalities in addition to the anteroapical region
- Valvular stenosis or regurgitation (tricuspid, aortic, or mitral valve) \> 2+
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Requires long-term dialysis for end-stage renal disease or onset of sepsis or active endocarditis
- Life expectancy at time of enrollment and hospitalization \<1 year
- Known allergies or contraindications to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast agents, that cannot be sufficiently treated with medication before surgery
- Cardiogenic shock within 72 hours of screening
- Pregnant or planning to become pregnant during the study period
- Participated in a clinical trial of another drug or medical device within 30 days of screening
- The researchers have determined that patient compliance is poor and that the person will be unable to complete the study in accordance with the requirements
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02240940
Start Date
September 1 2014
End Date
June 1 2017
Last Update
June 22 2017
Active Locations (7)
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1
Chinese Academy of Medical Sciences Fu Wai Hospital
Beijing, Beijing Municipality, China
2
Peking University First Hospital
Beijing, Beijing Municipality, China
3
Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 310016
4
10th People's Hospital Affiliated to Tongji University
Shanghai, China