A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)

June 21, 2017 updated by: CardioKinetix, Inc

Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
331

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Paul's Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Heart
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California (USC)
      • Los Angeles, California, United States, 90069
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital - Heart and Vascular Institute of Florida
      • Delray Beach, Florida, United States, 33444
        • Delray Medical Center
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
      • Tampa, Florida, United States, 33613
        • Florida Hospital Tampa - Pepin Heart Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Heart Clinics
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital
      • Naperville, Illinois, United States, 60566
        • Advocate Medical Group - Midwest Heart Foundation
      • Springfield, Illinois, United States, 62701
        • Prairie Education and Research Cooperative - St. John's Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Heart Center of Indiana
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
      • Iowa City, Iowa, United States, 52242-1081
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Lexington, Kentucky, United States, 40504
        • St Joseph Hospital/Kentucky One
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital/Louisville
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48197
        • St. Joseph Mercy-Michigan Heart
      • Midland, Michigan, United States, 48670
        • MidMichigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Saint Paul, Minnesota, United States, 55102
        • United Heart and Vascular Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's MAHI
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Hospital
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack UMC
    • New York
      • Buffalo, New York, United States, 14203
        • Gates Vascular Institute/Buffalo General Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital - Cornell Campus
      • Rochester, New York, United States, 14643
        • Univ. Of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Lindner Research Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute/Riverside Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17062
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Healthcare Network Cardiology
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center - Presbyterian Hospital
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health Cardiovascular Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare - Turkey Creek Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas West Hospital
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • Texas Heart Institute at St. Luke's Episcopal Hospital
      • Houston, Texas, United States, 77056
        • The Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Heart and Vascular, Fairfax
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Clinical Inclusion Criteria:

  • Age ≥ 18 and ≤ 79 years.
  • Body Mass Index (BMI) ≤ 40.
  • Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.
  • Patient is not hospitalized at the time of enrollment.
  • Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.
  • The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
  • The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Inclusion Criteria based on Imaging:

  • 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE).
  • Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE.
  • Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram

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

Clinical Exclusion Criteria:

  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cardiogenic shock within 72 hours of enrollment.
  • Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.
  • Excessive wall motion abnormalities outside the anteroapical region.
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • End stage renal disease requiring chronic dialysis.
  • Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.
  • Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.
  • Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Active peptic ulcer or GI bleeding within the past 3 months.
  • A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Ongoing sepsis, including active endocarditis.
  • Life expectancy < 1 year due to associated non-cardiac co-morbid conditions or currently on the heart transplant lists.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from appropriate consent.
  • Currently participating in an investigational drug or another device study (prior to primary endpoint reached).
  • Female patients with childbearing potential and a positive urine pregnancy test .

Anatomical Exclusion Criteria:

  • Pre-existing prosthetic heart valve in mitral or aortic position.
  • Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.
  • Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT)
Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
No Intervention: All Appropriate Medical Therapy (AAMT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Death or re-hospitalization for Worsening Heart Failure (WHF)
Time Frame: At least 1 year
At least 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CardioKinetix, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco A Costa, MD, PhD, University Hospitals
  • Principal Investigator: Leslie Saxon, MD, University of Southern California

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VA0956

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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