Ischemic Heart FailureNCT02240940
PARACHUTE China Approval Trial
A study testing Parachute Implant in people with Ischemic Heart Failure, run by CardioKinetix, Inc at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ischemic Heart Failure
- What is being tested?
- Parachute Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesChina
- Study dates
- Sep 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Chinese Academy of Medical Sciences Fu Wai Hospital
Beijing, Beijing Municipality
Peking University First Hospital
Beijing, Beijing Municipality
Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310016
10th People's Hospital Affiliated to Tongji University
Shanghai
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Zhongshang Hospital of Fudan University
Shanghai
General Hospital of Shenyang Military Region
Shenyang
About this study
Official title: PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
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 this trial is to use the Parachute percutaneous left ventricular partitioning system to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease and provide the data required to gain Chinese regulatory approval.
Read the 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 myocardial infarction). This implant device, called the "Parachute," is a partitioning membrane placed inside the apex of an enlarged ventricle with motion abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance.
Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with a Parachute implant device (the study device). Patients will receive all appropriate medical therapy (AAMT) approved by their physician.
The patient cohort will include patients with heart failure who have wall motion abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40% and ≥15%, and NYHA class II - IV（non-hospitalized). A maximum of 30 patients will be enrolled at seven centers. Patients who have passed screening with transthoracic echocardiography (TTE) and cardiac CT or MRI will be enrolled in the trial.
After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute device and treated with warfarin/aspirin anticoagulation therapy.
In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation, TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will be done.
- Conditions
- Ischemic Heart Failure
- Being tested
- Parachute Implant
- Keywords
- Heart Failure, Volume Reduction, Pressure Reduction, Ischemic Heart Failure, LAD Infarct
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parachute ImplantDevice
CardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Parachute Implant | Experimental | Appropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI. Receives: Device: Parachute Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of LVESVi
The primary outcome measure is comparison of reduction in left ventricle end systolic volume index（LVESVi) after 3 months with baseline LVESVi. Evaluation will be performed via transthoracic echocardiography (TTE) by an independent central ultrasound laboratory (Yale University Clinical Research).
Measured: 3 months
Secondary outcomes (5)
Major Adverse Cardiac Events
Major adverse cardiac events (MACE) are defined as death from any cause, myocardial infarction, need for elective or urgent cardiac or thoracic aortic surgery or need for use of device or device surgery with a catheter as the basis of interventional therapy, or total renal failure requiring dialysis. The Kaplan-Meier method will be used to evaluate event-free survival after Parachute implantation.
Measured: 3 months
Improvement in NYHA Class
All patients will undergo NYHA class evaluation at each time point. At the 3-month follow-up visit, the percentage of patients who have improvement in NYHA class (an improvement of at least 1 in comparison with NYHA class at baseline) will be measured.
Measured: 3 months
Improvement in 6 minute walk test
The difference in the distance of the 6-minute walk will be measured by comparing the distance walked at the 3-month follow-up visit with the baseline distance walked.
Measured: 3 months
Improvement in Quality of Life
The difference in EQ5D score by comparing EQ5D score at the 3-month follow-up visit with the EQ5D score at baseline will be measured.
Measured: 3 months
Procedural Success
Technical success: Success in releasing the Parachute implant or successful completion of surgery.
Combined success：The release of all devices with no serious adverse events, additional intervention surgeries, embolisms, technical failures (displacement, loss, etc.) or other problems.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionJun 2017
Why it stopped: Company closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioKinetix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Chuangsi Medical Technology Co., Ltd., Peking University
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, MD, Study chair, Chinese Academy of Medical Sciences, Fu Wai HospitalYuejin Yang, MD, Principal investigator, Chinese Academy of Medical Sciences, Fu Wai HospitalYuong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240940
- Sponsor's protocol ID
- RD1735
- Status last verified
- Jun 2017
- First submitted
- 5 Sep 2014
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li J, Liu H, Liu Q, Liu C, Xiong W, Ma W, Zhang B, Dong S, Li T. Long-term prognosis analysis of PARACHUTE device implantation in patients with ischemic heart failure: a single-center experience of Chinese patients. J Cardiothorac Surg. 2021 Apr 20;16(1):98. doi: 10.1186/s13019-021-01484-0.
PubMed 33879206Yang YJ, Huo Y, Xu YW, Wang JA, Han YL, Ge JB, Zhang RY, Yan XY, Gao RL. Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study. Chin Med J (Engl). 2016 Sep 5;129(17):2058-62. doi: 10.4103/0366-6999.189048.
PubMed 27569231
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
- ClinicalTrials.gov ID
- NCT02240940
- Acronym / sponsor ID
- RD1735
- Conditions
- Ischemic Heart Failure
- Keywords
- Heart Failure, Volume Reduction, Pressure Reduction, Ischemic Heart Failure, LAD Infarct
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company closed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CardioKinetix, IncIndustry (pharma, biotech, devices)
- Collaborators
- Guangzhou Chuangsi Medical Technology Co., Ltd., Peking University
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 this trial is to use the Parachute percutaneous left ventricular partitioning system to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease and provide the data required to gain Chinese regulatory approval.
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 myocardial infarction). This implant device, called the "Parachute," is a partitioning membrane placed inside the apex of an enlarged ventricle with motion abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance.
Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with a Parachute implant device (the study device). Patients will receive all appropriate medical therapy (AAMT) approved by their physician.
The patient cohort will include patients with heart failure who have wall motion abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40% and ≥15%, and NYHA class II - IV（non-hospitalized). A maximum of 30 patients will be enrolled at seven centers. Patients who have passed screening with transthoracic echocardiography (TTE) and cardiac CT or MRI will be enrolled in the trial.
After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute device and treated with warfarin/aspirin anticoagulation therapy.
In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation, TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parachute Implant | Experimental | Device: Parachute ImplantAppropriate patients meeting inclusion / exclusion will be implanted with the Parachute device after screening with transthoracic echocardiography (TTE) and cardiac CT or MRI. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parachute ImplantCardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure. | Device | Parachute Implant |
Primary outcome
Reduction of LVESVi
Time frame: 3 months
The primary outcome measure is comparison of reduction in left ventricle end systolic volume index（LVESVi) after 3 months with baseline LVESVi. Evaluation will be performed via transthoracic echocardiography (TTE) by an independent central ultrasound laboratory (Yale University Clinical Research).
5 secondary outcomes
Major Adverse Cardiac Events
Time frame: 3 months
Improvement in NYHA Class
Time frame: 3 months
Improvement in 6 minute walk test
Time frame: 3 months
Improvement in Quality of Life
Time frame: 3 months
Procedural Success
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Company closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Derived from this study: PubMed 33879206Li J, Liu H, Liu Q, Liu C, Xiong W, Ma W, Zhang B, Dong S, Li T. Long-term prognosis analysis of PARACHUTE device implantation in patients with ischemic heart failure: a single-center experience of Chinese patients. J Cardiothorac Surg. 2021 Apr 20;16(1):98. doi: 10.1186/s13019-021-01484-0.
- Derived from this study: PubMed 27569231Yang YJ, Huo Y, Xu YW, Wang JA, Han YL, Ge JB, Zhang RY, Yan XY, Gao RL. Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study. Chin Med J (Engl). 2016 Sep 5;129(17):2058-62. doi: 10.4103/0366-6999.189048.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Runlin Gao, MD study chair
Chinese Academy of Medical Sciences, Fu Wai Hospital
Yuejin Yang, MD principal investigator
Chinese Academy of Medical Sciences, Fu Wai Hospital
Yuong Huo, MD principal investigator
Peking University First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parachute Implant in people with Ischemic Heart Failure, run by CardioKinetix, Inc at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of LVESVi (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240940, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.