A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)
2017年6月21日 更新者：CardioKinetix, Inc
Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease
Treatment of ischemic heart failure.
研究概览
地位
终止
研究类型
介入性
注册 (实际的)
331
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6E 1M7
- St. Paul's Hospital
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Arizona
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Phoenix、Arizona、美国、85013
- Arizona Heart
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Tucson、Arizona、美国、85724
- University of Arizona Medical Center
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Arkansas
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Little Rock、Arkansas、美国、72211
- Arkansas Heart
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California
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Los Angeles、California、美国、90033
- University of Southern California (USC)
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Los Angeles、California、美国、90069
- Cedars-Sinai Medical Center
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Sacramento、California、美国、95817
- UC Davis Medical Center
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Florida
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Clearwater、Florida、美国、33756
- Morton Plant Hospital - Heart and Vascular Institute of Florida
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Delray Beach、Florida、美国、33444
- Delray Medical Center
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Tallahassee、Florida、美国、32308
- Tallahassee Research Institute
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Tampa、Florida、美国、33613
- Florida Hospital Tampa - Pepin Heart Institute
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Georgia
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Atlanta、Georgia、美国、30309
- Piedmont Atlanta Hospital
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Idaho
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Coeur d'Alene、Idaho、美国、83814
- Kootenai Heart Clinics
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Illinois
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Evanston、Illinois、美国、60201
- Evanston Hospital
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Naperville、Illinois、美国、60566
- Advocate Medical Group - Midwest Heart Foundation
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Springfield、Illinois、美国、62701
- Prairie Education and Research Cooperative - St. John's Hospital
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Indiana
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Indianapolis、Indiana、美国、46260
- St. Vincent Heart Center of Indiana
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Iowa
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Des Moines、Iowa、美国、50266
- Iowa Heart Center
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Iowa City、Iowa、美国、52242-1081
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Hospital
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Kentucky
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Lexington、Kentucky、美国、40503
- Baptist Health Lexington
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Lexington、Kentucky、美国、40504
- St Joseph Hospital/Kentucky One
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Louisville、Kentucky、美国、40202
- Jewish Hospital/Louisville
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Louisiana
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Houma、Louisiana、美国、70360
- Cardiovascular Institute of the South
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New Orleans、Louisiana、美国、70121
- Ochsner Clinic Foundation
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New Orleans、Louisiana、美国、70112
- LSU Health Sciences Center
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48197
- St. Joseph Mercy-Michigan Heart
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Midland、Michigan、美国、48670
- MidMichigan Medical Center
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota Medical Center
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Saint Paul、Minnesota、美国、55102
- United Heart and Vascular Clinic
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Missouri
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Kansas City、Missouri、美国、64111
- St. Luke's MAHI
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Nebraska
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Lincoln、Nebraska、美国、68526
- Nebraska Heart Hospital
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New Jersey
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Browns Mills、New Jersey、美国、08015
- Deborah Heart and Lung Center
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Hackensack、New Jersey、美国、07601
- Hackensack UMC
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New York
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Buffalo、New York、美国、14203
- Gates Vascular Institute/Buffalo General Hospital
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New York、New York、美国、10029
- Mount Sinai Medical Center
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New York、New York、美国、10065
- New York Presbyterian Hospital - Cornell Campus
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Rochester、New York、美国、14643
- Univ. Of Rochester Medical Center
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Health
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Ohio
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Cincinnati、Ohio、美国、45219
- The Christ Hospital Lindner Research Center
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Cleveland、Ohio、美国、44106
- University Hospitals
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Columbus、Ohio、美国、43210
- The Ohio State University
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Columbus、Ohio、美国、43214
- Ohio Health Research Institute/Riverside Methodist Hospital
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Oklahoma Heart Hospital
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Oklahoma City、Oklahoma、美国、73112
- Integris Baptist Medical Center
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Pennsylvania
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Lancaster、Pennsylvania、美国、17062
- Lancaster General Hospital
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19141
- Einstein Healthcare Network Cardiology
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center - Presbyterian Hospital
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Wormleysburg、Pennsylvania、美国、17043
- Pinnacle Health Cardiovascular Institute
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Rhode Island
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Providence、Rhode Island、美国、02906
- The Miriam Hospital
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Tennessee
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Kingsport、Tennessee、美国、37660
- Wellmont Holston Valley Medical Center
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Knoxville、Tennessee、美国、37934
- Tennova Healthcare - Turkey Creek Medical Center
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Nashville、Tennessee、美国、37232
- Vanderbilt University
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Nashville、Tennessee、美国、37205
- Saint Thomas West Hospital
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Texas
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Austin、Texas、美国、78745
- Texas Cardiac Arrhythmia Research Foundation
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Houston、Texas、美国、77030
- Memorial Hermann Hospital
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Houston、Texas、美国、77030
- Texas Heart Institute at St. Luke's Episcopal Hospital
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Houston、Texas、美国、77056
- The Methodist Hospital
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah
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Virginia
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Falls Church、Virginia、美国、22042
- Inova Heart and Vascular, Fairfax
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Norfolk、Virginia、美国、23507
- Sentara Cardiovascular Research Institute
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University Medical Center
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Washington
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Seattle、Washington、美国、98122
- Swedish Medical Center
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Wisconsin
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Milwaukee、Wisconsin、美国、53215
- Aurora St. Luke's Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 79年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Parachute Implant and All Appropriate Medical Therapy (AAMT)
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CardioKinetix Parachute implant and all appropriate medical therapy
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无干预：All Appropriate Medical Therapy (AAMT)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Death or re-hospitalization for Worsening Heart Failure (WHF)
大体时间：At least 1 year
|
At least 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marco A Costa, MD, PhD、University Hospitals
- 首席研究员：Leslie Saxon, MD、University of Southern California
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2012年6月4日
首先提交符合 QC 标准的
2012年6月6日
首次发布 (估计)
2012年6月8日
研究记录更新
最后更新发布 (实际的)
2017年6月23日
上次提交的符合 QC 标准的更新
2017年6月21日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.