Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients (PARACHUTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT00573560
First received: December 12, 2007
Last updated: July 21, 2014
Last verified: July 2014

December 12, 2007
July 21, 2014
December 2007
January 2010   (final data collection date for primary outcome measure)
Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00573560 on ClinicalTrials.gov Archive Site
Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients
A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: VPD Implant System
Percutaneous introduction using standard catheterization techniques of the VPD Implant.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2014
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
  2. Diagnosis of heart failure for a minimum of 6 months prior to enrollment
  3. NYHA Class at time of enrollment, either:

    • NYHA Class III or 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 and ≥ 1 hospitalization for heart failure during 12-month period prior to enrollment
  4. LVEF ≤ 40% as measured by echocardiography
  5. Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use
  6. Eligible for cardiac surgery
  7. Between 18 and 74 years of age (inclusive)
  8. Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
  9. 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
  10. Provide written informed consent
  11. Agree to the protocol-required follow-up

Exclusion Criteria:

  1. Myocardial ischemia requiring PCI or CABG
  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 CRT device within 60 days of enrollment
  6. Patient diagnosed with significant valve disease (AI >1+; MR >2+) which may or may not require surgery
  7. Patient has received an ICD within 60 days of enrollment
  8. Patient has received a pacemaker within 60 days of enrollment
  9. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
  10. Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy
  11. Aortic valve replacement or repair
  12. Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg
  13. Resting heart rate more than 120 bpm
  14. Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium
  15. History of bleeding diathesis or a major coagulopathy (i.e. platelet count < 100,000 plts/ml whole blood; PTT or PT > 1.3 times control value)
  16. GI bleed requiring transfusion within the past 3 months
  17. Patient has suffered a stroke within the past 6 months
  18. Evidence of severe calcification in the VPD Implant attachment zone
  19. Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant
  20. History of Kawasaki's disease
  21. Patient has received a heart, lung, liver and/or kidney transplant
  22. Patient on dialysis or expected to require hemodialysis within 12 months
  23. Patient has chronic liver disease
  24. Patient has received intracardiac gene therapy or stem cell therapy
  25. Creatinine > 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure
  26. Hypersensitivity to contrast media
  27. Allergy or contraindication to clopidogrel or aspirin
  28. Evidence of ongoing infection (fever with temperature > 38°C and/or WBC > 15,000)
  29. 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.)
  30. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Serbia
 
NCT00573560
US PARACHUTE Protocol
Yes
CardioKinetix, Inc
CardioKinetix, Inc
Not Provided
Principal Investigator: William T Abraham, MD Ohio State University
CardioKinetix, Inc
July 2014

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