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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

February 15, 2011
May 12, 2014
July 2011
June 2014   (final data collection date for primary outcome measure)
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.
Assessment of procedural success [ 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.
Complete list of historical versions of study NCT01297296 on ClinicalTrials.gov Archive Site
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
Change in Left Ventricular Volume Indeces [ 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
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A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System
PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.

  • Heart Failure
  • Myocardial Infarction
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2018
June 2014   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT01297296
RD1051
No
CardioKinetix, Inc
CardioKinetix, Inc
Not Provided
Principal Investigator: Martyn Thomas, MD St. Thomas' Hospital
CardioKinetix, Inc
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP