Trial record 10 of 16 for:
Parachute
Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients (PARACHUTE)
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ClinicalTrials.gov Identifier: NCT00573560 |
Recruitment Status :
Completed
First Posted : December 14, 2007
Last Update Posted : June 22, 2017
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Sponsor:
CardioKinetix, Inc
Information provided by (Responsible Party):
CardioKinetix, Inc
Tracking Information | ||||
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First Submitted Date ICMJE | December 12, 2007 | |||
First Posted Date ICMJE | December 14, 2007 | |||
Last Update Posted Date | June 22, 2017 | |||
Study Start Date ICMJE | December 2007 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients | |||
Official Title ICMJE | A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Heart Failure | |||
Intervention ICMJE | Device: VPD Implant System
Percutaneous introduction using standard catheterization techniques of the VPD Implant.
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Study Arms ICMJE | Not Provided | |||
Publications * | Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 74 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Serbia, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00573560 | |||
Other Study ID Numbers ICMJE | US PARACHUTE Protocol | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | CardioKinetix, Inc | |||
Original Responsible Party | Gerard Champsaur, MD, Sr. Vice President Clinical Affairs and Chief Medical Officer, CardioKinetix, Inc. | |||
Current Study Sponsor ICMJE | CardioKinetix, Inc | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | CardioKinetix, Inc | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |