A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)

Tracking Information
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; (submitted: June 6, 2012)	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	Complete list of historical versions of study NCT01614652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Congestive Heart Failure; Left Ventricular (LV) Systolic Dysfunction
Intervention ICMJE	Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT); CardioKinetix Parachute implant and all appropriate medical therapy
Study Arms	Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT) Intervention: Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT); No Intervention: All Appropriate Medical Therapy (AAMT)
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.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: June 21, 2017)	331
Original Estimated Enrollment ICMJE; (submitted: June 6, 2012)	478
Actual Study Completion Date	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: Age ≥ 18 and ≤ 79 years.; Body Mass Index (BMI) ≤ 40.; Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.; Patient is not hospitalized at the time of enrollment.; Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.; The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.; The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits. Inclusion Criteria based on Imaging: 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE).; Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE.; Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram Candidates will be excluded from the study if ANY of the following conditions apply: Clinical Exclusion Criteria: Untreated clinically significant coronary artery disease requiring revascularization.; Cardiogenic shock within 72 hours of enrollment.; Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.; Excessive wall motion abnormalities outside the anteroapical region.; Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).; End stage renal disease requiring chronic dialysis.; Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.; Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.; Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.; Active peptic ulcer or GI bleeding within the past 3 months.; A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.; Ongoing sepsis, including active endocarditis.; Life expectancy < 1 year due to associated non-cardiac co-morbid conditions or currently on the heart transplant lists.; Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from appropriate consent.; Currently participating in an investigational drug or another device study (prior to primary endpoint reached).; Female patients with childbearing potential and a positive urine pregnancy test . Anatomical Exclusion Criteria: Pre-existing prosthetic heart valve in mitral or aortic position.; Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.; Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 79 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	CardioKinetix, Inc
Study Sponsor ICMJE	CardioKinetix, Inc
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: William T Abraham, MD Ohio State University Principal Investigator: Marco A Costa, MD, PhD University Hospitals Principal Investigator: Leslie Saxon, MD University of Southern California
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