NCT02240940

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

September 5, 2014

Last Update Submit

June 21, 2017

Conditions

Ischemic Heart Failure

Keywords

Heart FailureVolume ReductionPressure ReductionIschemic Heart FailureLAD Infarct

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 months

Secondary Outcomes (5)

  • Major Adverse Cardiac Events

    3 months

  • Improvement in NYHA Class

    3 months

  • Improvement in 6 minute walk test

    3 months

  • Improvement in Quality of Life

    3 months

  • Procedural Success

    Day 0

Other Outcomes (1)

  • Long-term Safety

    6 months and 1 year

Study Arms (1)

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.

Device: Parachute Implant

Interventions

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.

Parachute Implant

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chinese Academy of Medical Sciences Fu Wai Hospital

Beijing, Beijing Municipality, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310016, China

Location

10th People's Hospital Affiliated to Tongji University

Shanghai, China

Location

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, China

Location

Zhongshang Hospital of Fudan University

Shanghai, China

Location

General Hospital of Shenyang Military Region

Shenyang, China

Location

Related Publications (2)

  • 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.

    PMID: 33879206DERIVED

  • Yang 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.

    PMID: 27569231DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Runlin Gao, MD

    Chinese Academy of Medical Sciences, Fu Wai Hospital

    STUDY CHAIR

  • Yuejin Yang, MD

    Chinese Academy of Medical Sciences, Fu Wai Hospital

    PRINCIPAL INVESTIGATOR

  • Yuong Huo, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations

CN(7)