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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01286116
First received: January 27, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Myocardial Infarction
Device: Parachute Implant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE

Resource links provided by NLM:


Further study details as provided by CardioKinetix, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Left Ventricular Volume Indexes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months


Enrollment: 59
Study Start Date: May 2011
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Parachute implant
Device: Parachute Implant
Mechanical ventricular partitioning

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286116

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

No publications provided by CardioKinetix, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioKinetix, Inc
ClinicalTrials.gov Identifier: NCT01286116     History of Changes
Other Study ID Numbers: VA0444
Study First Received: January 27, 2011
Last Updated: April 10, 2013
Health Authority: Germany: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Portugal: National Pharmacy and Medicines Institute
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovenia: Ministry of Health
Latvia: State Agency of Medicines

Keywords provided by CardioKinetix, Inc:
heart failure
percutaneous
interventional cardiology
apical remodeling
LV dilatation
akinesis
dyskinesis
myocardial infarction

Additional relevant MeSH terms:
Infarction
Heart Failure
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014