A Multinational Trial To Evaluate The Parachute Implant System (PARACHUTE)

June 21, 2017 updated by: CardioKinetix, Inc

A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE

The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

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

  • France
      • Bron, France, 69500
        • Hospital of Cardiology Louis Pradel (Lyon)
      • Massy, France, 91300
        • Institut Cardiovasculaire Paris-Sud
  • Germany
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Rostock, Germany, 18057
        • Universität Rostock
  • Latvia
      • Riga, Latvia, LV1002
        • Pauls Stradins Clinical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1005 AZ
        • University of Amsterdam AMC
  • Portugal
      • Lisbon, Portugal, 1169-024
        • Hospital Santa Marta
      • Vila Nova de Gaia, Portugal, 4430-502
        • Centro Hospitalar de Vila Nova de Gaia
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia (KCS)
  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)
  • United Kingdom
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital
      • London, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
      • London, United Kingdom, W1G 8PH
        • University College of London (The Heart Hospital)

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidates for this study must meet ALL of the following inclusion criteria:

    1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
    2. Subject is not hospitalized at time of enrollment.
    3. Diagnosis of heart failure for a minimum of 6 months prior to enrollment

    4. NYHA Class at time of enrollment, either:

      • NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment
      • NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
    5. LVEF >15% and ≤ 40% as measured by echocardiography.
    6. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
    7. Eligible for cardiac surgery
    8. Between 18 and 79 years of age (inclusive)
    9. Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
    10. Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
    11. Provide written informed consent
    12. Agree to the protocol-required follow-up

Exclusion Criteria:

Candidates will be excluded from the study if ANY of the following conditions apply:

  1. Untreated clinically significant coronary artery disease requiring intervention.
  2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
  3. Cardiogenic shock within 72 hours of enrollment
  4. Revascularization procedure (PCI or CABG) within 60 days of enrollment
  5. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
  6. Moderate aortic stenosis and regurgitation (aortic or mitral) >2+.
  7. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
  8. A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
  9. Aortic valve replacement or repair
  10. Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  11. Active peptic ulcer or GI bleeding within the past 3 months
  12. Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  13. History of Kawasaki's disease
  14. Patient has received a heart, lung, liver and/or kidney transplant
  15. Patient on dialysis or expected to require hemodialysis within 12 months
  16. Patient has chronic liver disease
  17. Impaired renal function that places patient at risk of contrast induced renal failure
  18. Ongoing sepsis, including active endocarditis.
  19. Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
  20. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

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: Treatment
Parachute implant
Device: Parachute Implant
Mechanical ventricular partitioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)
Time Frame: 6-months
Assessment of safety defined as the successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Volume Indexes.
Time Frame: 6 months
Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months
6 months

Collaborators and Investigators

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

Sponsor

CardioKinetix, Inc

Investigators

  • Principal Investigator: Martyn Thomas, MD, St. Thomas' Hospital

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

May 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA0444

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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