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Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study) (Partical)

Primary Purpose

Efficacy, Safty, Device

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
percutaneous ventricular restoration using heartech® device
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy, Safty, Device

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PVR implantation group

Arm Description

Patients enrolled receive PVR intervention

Outcomes

Primary Outcome Measures

Incidence of MACCE [primary safety]
major adverse cardiovascular events (MACCE)
LVESVi Reduction [primary efficacy]
left ventricular systolic volume index (LVESVi) reduction

Secondary Outcome Measures

Procedure Success
success rate of the procedure
Mortality
all-cause mortality rate
Cardiac death
cardiac death rate
Rehospitalization
rehospitalization rate
Incidence of MACCE
MACCE occurrence rate
LVESVi Reduction
left ventricular end systolic volume index (LVESVi) change
LVEDVi Reduction
left ventricular end-diastolic volume index (LVEDVi)
LVEF change
left ventricular ejection fraction (LVEF) detected by echocardiography
Cardiac function
cardiac function evaluation (NYHA classification)
Walk tolerance
6 minutes walk test
life quality
quality of life (EQ-5D)

Full Information

First Posted
July 28, 2019
Last Updated
January 9, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04039256
Brief Title
Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study)
Acronym
Partical
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Safty, Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVR implantation group
Arm Type
Experimental
Arm Description
Patients enrolled receive PVR intervention
Intervention Type
Device
Intervention Name(s)
percutaneous ventricular restoration using heartech® device
Intervention Description
Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.
Primary Outcome Measure Information:
Title
Incidence of MACCE [primary safety]
Description
major adverse cardiovascular events (MACCE)
Time Frame
30 days
Title
LVESVi Reduction [primary efficacy]
Description
left ventricular systolic volume index (LVESVi) reduction
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Procedure Success
Description
success rate of the procedure
Time Frame
immediate
Title
Mortality
Description
all-cause mortality rate
Time Frame
12 month
Title
Cardiac death
Description
cardiac death rate
Time Frame
12 month
Title
Rehospitalization
Description
rehospitalization rate
Time Frame
12 month
Title
Incidence of MACCE
Description
MACCE occurrence rate
Time Frame
12 month
Title
LVESVi Reduction
Description
left ventricular end systolic volume index (LVESVi) change
Time Frame
12 month
Title
LVEDVi Reduction
Description
left ventricular end-diastolic volume index (LVEDVi)
Time Frame
12 month
Title
LVEF change
Description
left ventricular ejection fraction (LVEF) detected by echocardiography
Time Frame
12 month
Title
Cardiac function
Description
cardiac function evaluation (NYHA classification)
Time Frame
12 month
Title
Walk tolerance
Description
6 minutes walk test
Time Frame
12 month
Title
life quality
Description
quality of life (EQ-5D)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengbin Zhu, M.D Ph.D.
Phone
021-64370045
Ext
673344
Email
zzb11561@rhj.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fenghua Ding, MD. Ph.D.
Organizational Affiliation
Cardiovascular research instittion, Shanghai Jiao Tong University
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD.
Phone
86-21-64370045
Ext
665215
Email
zhangruiyan@263.net
First Name & Middle Initial & Last Name & Degree
Zhengbin Zhu, MD.
Phone
86-21-64370045
Ext
665380
Email
gemini198306@163.com
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31231944
Citation
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.
Results Reference
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Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study)

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