Efficacy, Safty, DeviceParticalNCT04039256
Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study)
A study testing percutaneous ventricular restoration using heartech® device in people with Efficacy, Safty, Device, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a prospective, multi-center, single-group, target-value clinical study. The primary safety end points are major adverse cardiovascular events (MACCE) 30 days after device implantation. The primary efficacy end point is the end of left ventricular systolic volume index (LVESVI) reduction at 6 month. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Efficacy, Safty, Device
- What is being tested?
- percutaneous ventricular restoration using heartech® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2020to 31 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI<40;
- left ventricular ejection fraction ≤45% and ≥20%;
- patients with left ventricular end-systolic volume index (ESVI) ≥50mL/m2;
- transthoracic ultrasound showed contradictory motion of the left ventricle after myocardial infarction;
- 60 days prior to anterior wall myocardial infarction with ischemic heart failure (NYHA grade II to "not hospitalized" grade IV);
- the left ventricle must have the appropriate anatomic structure (size and shape) which is confirmed by cardiac CT and left ventricular angiography to implant the appropriate Heartech® device;
- agree to receive reasonable treatment according to current ACC/AHA and Chinese guidelines for heart failure diagnosis and treatment;
- the subjects or their legal representatives are informed of the nature of this study and agree to participate in all the terms of this study, sign the informed consent approved by the ethics committee, agree to accept the postoperative treatment plan and follow-up requirements, and can complete the examination of follow-up.
Who cannot join
- patients whose left ventricular anatomy is not suitable for Heartech® occlusal device implantation;
- the abnormal ventricular wall movement not contains the anterior wall of the left ventricle, the apex of the left ventricle and the ventricular septum;
- patients with thrombosis in the left ventricle;
- mitral stenosis or regurgitation (tricuspid, aortic or mitral) > 2+ (moderate);
- recent (within 6 month) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- end-stage renal disease requiring long-term dialysis, episodic sepsis or active phase endocarditis;
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- life expectancy at admission < 1 year;
- known allergy to aspirin, heparin, warfarin, Nitinol (alloys of titanium and nickel) or contraindications, or sensitivity to contrast agents;
- cardiogenic shock occurred within 72 hours before procedure;
- pregnancy or planned pregnancy during the study period;
- participated in clinical trials of other drugs or medical devices during the same period;
- the researcher judged that the patient had poor compliance and could not complete the study as required;
- other conditions considered unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Ruiyan Zhang, MD., 86-21-64370045 ext. 665215, zhangruiyan@263.net
Zhengbin Zhu, MD., 86-21-64370045 ext. 665380, gemini198306@163.com
About this study
Official title: Efficacy And Safty of Heartech® Left Ventricular Partitioning Device In Treating Heart Failure Post Myocardial Infarction (Phase II Clinical Trial: The Partical Study)
This is a prospective, multi-center, single-group, target-value clinical study. The primary safety end points are major adverse cardiovascular events (MACCE) 30 days after device implantation.
The primary efficacy end point is the end of left ventricular systolic volume index (LVESVI) reduction at 6 month.
Read more
The secondary observational end points includes immediate success rate of the procedure, all-cause mortality, cardiac death, rehospitalization rates and MACCE occurrence rate within 12 month. Besides, left ventricular end systolic volume index (LVESVI) change at 30 days,12 months, left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), 6 minutes walk test, heart function evaluation (NYHA classification) and quality of life (EQ-5D) at 30 days, 6 months, 12 months will also be evaluated.
After statistical hypothesis and sample size estimation, the sample size of this clinical trial was 117 cases. All subjects were followed up 30 days, 6 months and 12 months after implantation of the Heartech® left ventricular partitioning device. All relevant clinical data were managed by professional data management center, and all relevant clinical data were statistically analyzed by third-party statistical center.
Read the detailed description
MACCE includes all-cause death, myocardial infarction, stroke and any elective or emergency cardiac or thoracic aortic surgery or catheter-based interventional therapy.
- Conditions
- Efficacy, Safty, Device
- Being tested
- percutaneous ventricular restoration using heartech® device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous ventricular restoration using heartech® deviceDevice
Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.
| Study group | Role | What they receive |
|---|---|---|
| PVR implantation group | Experimental | Patients enrolled receive PVR intervention Receives: Device: percutaneous ventricular restoration using heartech® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACCE [primary safety]
major adverse cardiovascular events (MACCE)
Measured: 30 days
LVESVi Reduction [primary efficacy]
left ventricular systolic volume index (LVESVi) reduction
Measured: 6 month
Secondary outcomes (11)
Procedure Success
success rate of the procedure
Measured: immediate
Mortality
all-cause mortality rate
Measured: 12 month
Cardiac death
cardiac death rate
Measured: 12 month
Rehospitalization
rehospitalization rate
Measured: 12 month
Incidence of MACCE
MACCE occurrence rate
Measured: 12 month
LVESVi Reduction
left ventricular end systolic volume index (LVESVi) change
Measured: 12 month
LVEDVi Reduction
left ventricular end-diastolic volume index (LVEDVi)
Measured: 12 month
LVEF change
left ventricular ejection fraction (LVEF) detected by echocardiography
Measured: 12 month
Cardiac function
cardiac function evaluation (NYHA classification)
Measured: 12 month
Walk tolerance
6 minutes walk test
Measured: 12 month
life quality
quality of life (EQ-5D)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start2 Jan 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy, Safty, DeviceStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Fenghua Ding, MD. Ph.D., Study director, Cardiovascular research instittion, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039256
- Sponsor's protocol ID
- RJH-20190728
- Acronym
- Partical
- Status last verified
- Jan 2020
- First submitted
- 28 Jul 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Z, Yu J, Xu K, Tang Y, Fang Y, Gu J, Gu S, Ding F, Modine T, Zhang R. First-in-man study of Heartech(R) percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction. Catheter Cardiovasc Interv. 2019 Nov 15;94(6):845-853. doi: 10.1002/ccd.28366. Epub 2019 Jun 23.
PubMed 31231944
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safty of Heartech® Left Ventricular Partitioning Device In Treating Heart Failure Post Myocardial Infarction (Phase II Clinical Trial: The Partical Study)
- ClinicalTrials.gov ID
- NCT04039256
- Acronym / sponsor ID
- Partical / RJH-20190728
- Conditions
- Efficacy, Safty, Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 31 Jul 2019 (actual)
- 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.
This is a prospective, multi-center, single-group, target-value clinical study. The primary safety end points are major adverse cardiovascular events (MACCE) 30 days after device implantation.
The primary efficacy end point is the end of left ventricular systolic volume index (LVESVI) reduction at 6 month.
The secondary observational end points includes immediate success rate of the procedure, all-cause mortality, cardiac death, rehospitalization rates and MACCE occurrence rate within 12 month. Besides, left ventricular end systolic volume index (LVESVI) change at 30 days,12 months, left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), 6 minutes walk test, heart function evaluation (NYHA classification) and quality of life (EQ-5D) at 30 days, 6 months, 12 months will also be evaluated.
After statistical hypothesis and sample size estimation, the sample size of this clinical trial was 117 cases. All subjects were followed up 30 days, 6 months and 12 months after implantation of the Heartech® left ventricular partitioning device. All relevant clinical data were managed by professional data management center, and all relevant clinical data were statistically analyzed by third-party statistical center.
Detailed description
MACCE includes all-cause death, myocardial infarction, stroke and any elective or emergency cardiac or thoracic aortic surgery or catheter-based interventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVR implantation group | Experimental | Device: percutaneous ventricular restoration using heartech® devicePatients enrolled receive PVR intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI<40;
- left ventricular ejection fraction ≤45% and ≥20%;
- patients with left ventricular end-systolic volume index (ESVI) ≥50mL/m2;
- transthoracic ultrasound showed contradictory motion of the left ventricle after myocardial infarction;
- 60 days prior to anterior wall myocardial infarction with ischemic heart failure (NYHA grade II to "not hospitalized" grade IV);
Key exclusion criteria (13 listed)
- patients whose left ventricular anatomy is not suitable for Heartech® occlusal device implantation;
- the abnormal ventricular wall movement not contains the anterior wall of the left ventricle, the apex of the left ventricle and the ventricular septum;
- patients with thrombosis in the left ventricle;
- mitral stenosis or regurgitation (tricuspid, aortic or mitral) > 2+ (moderate);
- recent (within 6 month) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
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 |
|---|---|---|
| percutaneous ventricular restoration using heartech® devicePatients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation. | Device | PVR implantation group |
Primary outcome
Incidence of MACCE [primary safety]
Time frame: 30 days
major adverse cardiovascular events (MACCE)
LVESVi Reduction [primary efficacy]
Time frame: 6 month
left ventricular systolic volume index (LVESVi) reduction
11 secondary outcomes
Procedure Success
Time frame: immediate
Mortality
Time frame: 12 month
Cardiac death
Time frame: 12 month
Rehospitalization
Time frame: 12 month
Incidence of MACCE
Time frame: 12 month
LVESVi Reduction
Time frame: 12 month
LVEDVi Reduction
Time frame: 12 month
LVEF change
Time frame: 12 month
Cardiac function
Time frame: 12 month
Walk tolerance
Time frame: 12 month
life quality
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 31231944Zhu Z, Yu J, Xu K, Tang Y, Fang Y, Gu J, Gu S, Ding F, Modine T, Zhang R. First-in-man study of Heartech(R) percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction. Catheter Cardiovasc Interv. 2019 Nov 15;94(6):845-853. doi: 10.1002/ccd.28366. Epub 2019 Jun 23.
- Individual participant dataSharing planned: No
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.
Fenghua Ding, MD. Ph.D. study director
Cardiovascular research instittion, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous ventricular restoration using heartech® device in people with Efficacy, Safty, Device, run by Shanghai Jiao Tong University School of Medicine at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengbin Zhu, M.D Ph.D. (021-64370045 ext. 673344, zzb11561@rhj.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MACCE [primary safety] (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04039256, which also lists 1 linked publication.
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 13 Jan 2020.