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

January 9, 2020 updated by: Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruiyan Zhang, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVR implantation group
Patients enrolled receive PVR intervention
Device: percutaneous ventricular restoration using heartech® device
Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of MACCE [primary safety]
Time Frame: 30 days
major adverse cardiovascular events (MACCE)
30 days
LVESVi Reduction [primary efficacy]
Time Frame: 6 month
left ventricular systolic volume index (LVESVi) reduction
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: immediate
success rate of the procedure
immediate
Mortality
Time Frame: 12 month
all-cause mortality rate
12 month
Cardiac death
Time Frame: 12 month
cardiac death rate
12 month
Rehospitalization
Time Frame: 12 month
rehospitalization rate
12 month
Incidence of MACCE
Time Frame: 12 month
MACCE occurrence rate
12 month
LVESVi Reduction
Time Frame: 12 month
left ventricular end systolic volume index (LVESVi) change
12 month
LVEDVi Reduction
Time Frame: 12 month
left ventricular end-diastolic volume index (LVEDVi)
12 month
LVEF change
Time Frame: 12 month
left ventricular ejection fraction (LVEF) detected by echocardiography
12 month
Cardiac function
Time Frame: 12 month
cardiac function evaluation (NYHA classification)
12 month
Walk tolerance
Time Frame: 12 month
6 minutes walk test
12 month
life quality
Time Frame: 12 month
quality of life (EQ-5D)
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Fenghua Ding, MD. Ph.D., Cardiovascular research instittion, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

July 28, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-20190728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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