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Heart FailurePhase 3PARACHUTENCT01286116

A Multinational Trial To Evaluate The Parachute Implant System

A Phase 3 study testing Parachute Implant in people with Heart Failure and Myocardial Infarction, run by CardioKinetix, Inc at 13 sites in 8 countries.

Terminated

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

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Heart Failure, Myocardial Infarction
What is being tested?
Parachute Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
13 sitesin 8 countries
Study dates
May 2011to 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

  • Candidates for this study must meet ALL of the following inclusion criteria:
  • Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
  • Subject is not hospitalized at time of enrollment.
  • Diagnosis of heart failure for a minimum of 6 months prior to enrollment
  • NYHA Class at time of enrollment, either:
  • NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment
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  • NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
  • LVEF >15% and ≤ 40% as measured by echocardiography.
  • Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
  • Eligible for cardiac surgery
  • Between 18 and 79 years of age (inclusive)
  • 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
  • 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
  • Provide written informed consent
  • Agree to the protocol-required follow-up

Who cannot join

  • Candidates will be excluded from the study if ANY of the following conditions apply:
  • Untreated clinically significant coronary artery disease requiring intervention.
  • Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
  • Cardiogenic shock within 72 hours of enrollment
  • Revascularization procedure (PCI or CABG) within 60 days of enrollment
  • Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
Show all 21Show fewer
  • Moderate aortic stenosis and regurgitation (aortic or mitral) >2+.
  • History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
  • 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.
  • Aortic valve replacement or repair
  • Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Active peptic ulcer or GI bleeding within the past 3 months
  • Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  • History of Kawasaki's disease
  • Patient has received a heart, lung, liver and/or kidney transplant
  • Patient on dialysis or expected to require hemodialysis within 12 months
  • Patient has chronic liver disease
  • Impaired renal function that places patient at risk of contrast induced renal failure
  • Ongoing sepsis, including active endocarditis.
  • 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.)
  • Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

Trial locations and contacts

13 sites in 8 countries.

13 sites in 8 countries

United Kingdom3 sites

  • Papworth Hospital

    Cambridge, CB23 3RE

  • St. Thomas' Hospital

    London, SE1 7EH

  • University College of London (The Heart Hospital)

    London, W1G 8PH

Other trials in United Kingdom

France2 sites

  • Hospital of Cardiology Louis Pradel (Lyon)

    Bron, 69500

  • Institut Cardiovasculaire Paris-Sud

    Massy, 91300

Other trials in France

Germany2 sites

  • University of Heidelberg

    Heidelberg, 69120

  • Universitat Rostock

    Rostock, 18057

Other trials in Germany

Portugal2 sites

  • Hospital Santa Marta

    Lisbon, 1169-024

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4430-502

Other trials in Portugal

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

Netherlands1 site

  • University of Amsterdam AMC

    Amsterdam, 1005 AZ

Other trials in Netherlands

Serbia1 site

  • Clinical Center of Serbia (KCS)

    Belgrade, 11000

Other trials in Serbia

Slovenia1 site

  • Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)

    Ljubljana, 1525

Other trials in Slovenia

About this study

Official title: 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.

Read the 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.

Being tested
Parachute Implant
Keywords
heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis, myocardial infarction
Medical subject headings
Heart Failure, Myocardial Infarction, Dyskinesias

What participants receive

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

  • Parachute ImplantDevice

    Mechanical ventricular partitioning

Study groups in NCT01286116
Study groupRoleWhat they receive
TreatmentExperimentalParachute implant
Receives: Device: Parachute Implant

What is being measured

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

  1. The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)

    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.

    Measured: 6-months

Secondary outcomes (1)

  1. Change in Left Ventricular Volume Indexes.

    Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months

    Measured: 6 months

Timeline

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

  1. First posted31 Jan 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2013
  4. Study completionJun 2017

Why it stopped: Company 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01286116
Sponsor's protocol ID
VA0444
Acronym
PARACHUTE
Status last verified
Jun 2017
First submitted
27 Jan 2011
Last updated
23 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18.

    PubMed 25037310

  • 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 Parachute Implant in people with Heart Failure and Myocardial Infarction, run by CardioKinetix, Inc at 13 sites in 8 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 15 inclusion and 21 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 13 sites in United Kingdom, France, Germany, Portugal, Latvia and 3 more countries. 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 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?

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). 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 NCT01286116, which also lists 2 linked publications.

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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