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PARACHUTE China Approval Trial

NCT02240940 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-22

No results posted yet for this study

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.

Conditions

  • Ischemic Heart Failure

Interventions

DEVICE

Parachute Implant

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.

Sponsors & Collaborators

  • Guangzhou Chuangsi Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Peking University

    collaborator OTHER

  • CardioKinetix, Inc

    lead INDUSTRY

Principal Investigators

  • Runlin Gao, MD · Chinese Academy of Medical Sciences, Fu Wai Hospital

  • Yuejin Yang, MD · Chinese Academy of Medical Sciences, Fu Wai Hospital

  • Yuong Huo, MD · Peking University First Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-05-31
Completion
2017-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02240940 on ClinicalTrials.gov