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Congestive Heart FailurePhase 3PARACHUTE IVNCT01614652

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

A Phase 3 study testing CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT) in people with Congestive Heart Failure and Left Ventricular (LV) Systolic Dysfunction, run by CardioKinetix, Inc at 68 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Treatment of ischemic heart failure. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
68 sitesin 2 countries
Study dates
Dec 2012to Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

United States67 sites

  • St. Joseph Mercy-Michigan Heart

    Ann Arbor, Michigan, 48197

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78745

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Gates Vascular Institute/Buffalo General Hospital

    Buffalo, New York, 14203

  • The Christ Hospital Lindner Research Center

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital - Heart and Vascular Institute of Florida

    Clearwater, Florida, 33756

  • University Hospitals

    Cleveland, Ohio, 44106

  • Kootenai Heart Clinics

    Coeur d'Alene, Idaho, 83814

  • The Ohio State University

    Columbus, Ohio, 43210

  • Ohio Health Research Institute/Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Delray Medical Center

    Delray Beach, Florida, 33444

  • Iowa Heart Center

    Des Moines, Iowa, 50266

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Heart and Vascular, Fairfax

    Falls Church, Virginia, 22042

  • Hackensack UMC

    Hackensack, New Jersey, 07601

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Texas Heart Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77056

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242-1081

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's MAHI

    Kansas City, Missouri, 64111

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17062

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • St Joseph Hospital/Kentucky One

    Lexington, Kentucky, 40504

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

  • Arkansas Heart

    Little Rock, Arkansas, 72211

  • University of Southern California (USC)

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90069

  • Jewish Hospital/Louisville

    Louisville, Kentucky, 40202

  • MidMichigan Medical Center

    Midland, Michigan, 48670

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Advocate Medical Group - Midwest Heart Foundation

    Naperville, Illinois, 60566

  • Saint Thomas West Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10065

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Einstein Healthcare Network Cardiology

    Philadelphia, Pennsylvania, 19141

  • Arizona Heart

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center - Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • Univ. Of Rochester Medical Center

    Rochester, New York, 14643

  • UC Davis Medical Center

    Sacramento, California, 95817

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102

  • University of Utah

    Salt Lake City, Utah, 84132

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Prairie Education and Research Cooperative - St. John's Hospital

    Springfield, Illinois, 62701

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Florida Hospital Tampa - Pepin Heart Institute

    Tampa, Florida, 33613

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Canada1 site

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

About this study

Official title: Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.

Being tested
CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Keywords
Congestive Heart Failure Due to LV Systolic Dysfunction
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)Device

    CardioKinetix Parachute implant and all appropriate medical therapy

Study groups in NCT01614652
Study groupRoleWhat they receive
Parachute Implant and All Appropriate Medical Therapy (AAMT)ExperimentalNot described
Receives: Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
All Appropriate Medical Therapy (AAMT)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death or re-hospitalization for Worsening Heart Failure (WHF)

    Measured: At least 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2017
  4. Study completionJun 2017

Why it stopped: Company is closed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614652
Sponsor's protocol ID
VA0956
Acronym
PARACHUTE IV
Status last verified
Jun 2017
First submitted
4 Jun 2012
Last updated
23 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Costa MA, Pencina M, Nikolic S, Engels T, Templin B, Abraham WT. The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J. 2013 Apr;165(4):531-6. doi: 10.1016/j.ahj.2012.12.022. Epub 2013 Feb 19.

    PubMed 23537969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT) in people with Congestive Heart Failure and Left Ventricular (LV) Systolic Dysfunction, run by CardioKinetix, Inc at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company is closed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death or re-hospitalization for Worsening Heart Failure (WHF) (time frame: At least 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01614652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.

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