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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01297296
First received: February 15, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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
Heart Failure
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System

Resource links provided by NLM:


Further study details as provided by CardioKinetix, Inc:

Primary Outcome Measures:
  • Assessment of long term safety of the Parachute system [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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:
  • Change in Left Ventricular Volume Indices [ Time Frame: 6 months and annually to 5 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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.

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. 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.)
  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: NCT01297296

Locations
Belgium
OLV Hospital Aalst
Aalst, Belgium, 9300
ZNA Middelheim
Antwerpen, Belgium, 2020
Germany
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
Italy
Ferrarotto University Hospital Catania
Catania, Italy, 95123
Netherlands
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3508
Spain
Hospital Clinico de Barcelona
Barcelona, Spain, 08028
United Kingdom
British Royal Infirmary (The Heart Centre)
Bristol, United Kingdom, BS2 8HW
Golden Jubilee Hospital
Glasgow, United Kingdom, G81 4DY
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

Responsible Party: CardioKinetix, Inc
ClinicalTrials.gov Identifier: NCT01297296     History of Changes
Other Study ID Numbers: RD1051
Study First Received: February 15, 2011
Last Updated: May 12, 2014
Health Authority: Germany: Ethics Commission
Belgium: Ethics Committee
United Kingdom: Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014