A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01614652 |
Recruitment Status :
Terminated
(Company is closed)
First Posted : June 8, 2012
Last Update Posted : June 23, 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 | June 4, 2012 | |||||||||
First Posted Date ICMJE | June 8, 2012 | |||||||||
Last Update Posted Date | June 23, 2017 | |||||||||
Study Start Date ICMJE | December 2012 | |||||||||
Actual Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Death or re-hospitalization for Worsening Heart Failure (WHF) [ Time Frame: At least 1 year ] | |||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System | |||||||||
Official Title ICMJE | Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease | |||||||||
Brief Summary | Treatment of ischemic heart failure. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
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Study Arms ICMJE |
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Publications * | Costa MA, Pencina M, Nikolic S, Engels T, Templin B, Abraham WT. The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J. 2013 Apr;165(4):531-6. doi: 10.1016/j.ahj.2012.12.022. Epub 2013 Feb 19. | |||||||||
* 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 | Terminated | |||||||||
Actual Enrollment ICMJE |
331 | |||||||||
Original Estimated Enrollment ICMJE |
478 | |||||||||
Actual Study Completion Date ICMJE | June 2017 | |||||||||
Actual Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Candidates for this study must meet ALL of the following inclusion criteria: Clinical Inclusion Criteria:
Inclusion Criteria based on Imaging:
Candidates will be excluded from the study if ANY of the following conditions apply: Clinical Exclusion Criteria:
Anatomical Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 79 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 | Canada, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01614652 | |||||||||
Other Study ID Numbers ICMJE | VA0956 | |||||||||
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 | Same as current | |||||||||
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 | June 2017 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |