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Trial record 2 of 2 for:    parachute iii

A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System (PARACHUTEIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297296
Recruitment Status : Terminated
First Posted : February 16, 2011
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
CardioKinetix, Inc

Brief Summary:
The primary objective is to assess the longterm 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.

Condition or disease
Heart Failure Myocardial Infarction

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 longterm 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.

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System
Study Start Date : July 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2017

Primary Outcome Measures :
  1. Assessment of long term safety of the Parachute system [ Time Frame: 5 years ]
    Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.

Secondary Outcome Measures :
  1. Change in Left Ventricular Volume Indices [ Time Frame: 6 months and annually to 5 years ]
    Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.

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. 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
    4. LVEF >15 or% and ≤ 40% as measured by echocardiography.
    5. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
    6. Eligible for cardiac surgery
    7. Between 18 and 79 years of age (inclusive)
    8. 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
    9. Provide written informed consent
    10. 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. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
  7. 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.
  8. Aortic valve replacement or repair
  9. Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  10. Active peptic ulcer or GI bleeding within the past 3 months
  11. Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  12. History of Kawasaki's disease
  13. Patient on dialysis or expected to require hemodialysis within 12 months
  14. Patient has chronic liver disease
  15. Impaired renal function that places patient at risk of contrast induced renal failure
  16. Ongoing sepsis, including active endocarditis.
  17. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297296

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OLV Hospital Aalst
Aalst, Belgium, 9300
ZNA Middelheim
Antwerpen, Belgium, 2020
Kerckhoff-Klinik SGmbh
Bad Nauheim, Germany, 61231
Arzt St. Marien-Hospital Abt. Innere Medizin
Bonn, Germany, 53115
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
University of Heidelberg
Heidelberg, Germany, 69120
University Hospital Leipzig
Leipzig, Germany, 04289
Universitat Rostok
Rostock, Germany, 18057
Ferrarotto University Hospital Catania
Catania, Italy, 95123
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3508
Hospital Clinico de Barcelona
Barcelona, Spain, 08028
United Kingdom
Golden Jubilee Hospital
Glasgow, United Kingdom, G81 4DY
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
CardioKinetix, Inc
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Principal Investigator: Simon Redwood, MD St. Thomas' Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CardioKinetix, Inc Identifier: NCT01297296    
Other Study ID Numbers: RD1051
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by CardioKinetix, Inc:
heart failure
interventional cardiology
apical remodeling
LV dilatation
myocardial infarction
Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases