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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 79
Updated:4/29/2017
Start Date:December 2012
End Date:July 2023

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Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.


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
We found this trial at
68
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Navin Kapur, MD
Phone: 617-636-4990
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar, MD
Phone: 310-248-8515
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: George Dangas, MD
Phone: 212-241-8228
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Joyce W. Wald, MD
Phone: 215-662-6590
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Sacramento, California 95814
Principal Investigator: Jason Rogers, MD
Phone: 916-734-5639
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: James Fang, MD
Phone: 801-585-7295
University of Utah Research is a major component in the life of the U benefiting...
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Ann Arbor, Michigan 48197
Principal Investigator: Marlo F. Leonen, MD
Phone: 734-712-7602
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Atlanta, Georgia 30309
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Austin, Texas 78758
Principal Investigator: John Dieck, MD
Phone: 512-458-9410
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Mukta Srivastava, MD
Phone: 410-328-8790
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Browns Mills, New Jersey 08015
Principal Investigator: Richard Kovach, MD
Phone: 609-893-5028
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Buffalo, New York 14203
Principal Investigator: Joseph Gelormini, MD
Phone: 716-835-2966
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3805 Edwards Road
Cincinnati, Ohio 45129
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Clearwater, Florida 33756
Principal Investigator: Patrick Cambier, MD
Phone: 727-723-6511
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Cleveland, Ohio 44106
Principal Investigator: Daniel Simon, MD
Phone: 216-844-2636
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Coeur d'Alene, Idaho 83814
Principal Investigator: Ronald D Jenkins, MD
Phone: 208-676-9913
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Ernest Mazzaferri, MD
Phone: 614-247-6797
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, Ohio 43214
Principal Investigator: Lee W. Jordan, MD
Phone: 614-566-1274
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Delray Beach, Florida 33431
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Des Moines, Iowa 50314
Principal Investigator: Mark Tannenbaum, MD
Phone: 515-235-5114
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2650 Ridge Ave.
Evanston, Illinois 60201
847.570.2000
Principal Investigator: Ted Feldman, MD
Phone: 847-570-2366
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Falls Church, Virginia 22042
Principal Investigator: Shahram Yazdani, MD
Phone: 703-776-6007
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Hackensack, New Jersey 07601
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Houma, Louisiana 70360
Principal Investigator: Peter Fail, MD
Phone: 985-873-5613
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Houston, Texas 77030
Principal Investigator: Bijwajit Kar, MD
Phone: 713-500-7575
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Houston, Texas 77030
Principal Investigator: Emerson Perin, MD
Phone: 832-355-9366
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Houston, Texas 77030
Principal Investigator: Neal S. Kleiman, MD
Phone: 713-363-7995
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Indianapolis, Indiana 46260
Principal Investigator: James Hermiller, MD
Phone: 317-338-6151
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Phillip Horwitz, MD
Phone: 319-384-8005
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Kansas 66160
Principal Investigator: Mark Wiley, MD
Phone: 913-588-9627
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Kansas City, Missouri 64111
Principal Investigator: Andrew Kao, MD
Phone: 816-932-1627
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Kingsport, Tennessee 37660
Principal Investigator: Christopher Metzger, MD
Phone: 423-230-5618
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Knoxville, Tennessee 37934
Principal Investigator: Malcolm T. Foster, MD
Phone: 865-218-7539
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Justin Roberts, DO
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lexington, Kentucky 40503
Principal Investigator: Gery Tomassoni, MD
Phone: 859-260-6066
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1 Saint Joseph Drive
Lexington, Kentucky 40504
Principal Investigator: Nezar Falluji, MD
Phone: 859-313-4161
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Lincoln, Nebraska 68526
Principal Investigator: Steven Martin, MD
Phone: 402-328-3930
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Little Rock, Arkansas 72211
Principal Investigator: Carl J. Leding, MD
Phone: 501-748-8408
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Los Angeles, California 90007
Principal Investigator: Rahul Doshi, MD
Phone: 323-442-7983
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200 Abraham Flexner Way
Louisville, Kentucky 40202
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Midland, Michigan 48670
Principal Investigator: Andrzej Boguszewski, MD
Phone: 989-631-2469
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Suhail Allaqaband, MD
Phone: 414-385-1853
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55455
Principal Investigator: Gladwin Suseekar Das, MD
Phone: 612-626-3656
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Naperville, Illinois 60566
Principal Investigator: Mark Goodwin, MD
Phone: 630-873-3405
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Nashville, Tennessee 37205
Principal Investigator: Andrew Morse, MD
Phone: 615-222-3862
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New Orleans, Louisiana 70112
Principal Investigator: Frank Smart, MD
Phone: 504-568-2349
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New Orleans, Louisiana 70121
Principal Investigator: J. Stephen Jenkins, MD
Phone: 504-842-6832
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New York, New York 10021
Principal Investigator: S. Chiu Wong, MD
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Norfolk, Virginia 23507
Principal Investigator: Allen Ciuffo, MD
Phone: 757-388-1568
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Oklahoma City, Oklahoma
Principal Investigator: George Chrysant, MD
Phone: 405-951-2894
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Oklahoma City, Oklahoma 73120
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5501 Old York Road
Philadelphia, Pennsylvania 19141
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Phoenix, Arizona 85016
Principal Investigator: Vijendra Swarup, MD
Phone: 602-456-2342
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Catalin Toma, MD
Phone: 412-647-6210
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Dave Lasorda, MD
Phone: 412-359-6860
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Paul Gordon, MD
Phone: 401-793-4105
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Zachary Gertz, MD
Phone: 804-828-1601
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Saint Paul, Minnesota 55102
Principal Investigator: Bilal Murad, MD
Phone: 651-241-2811
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Paul Huang, MD
Phone: 206-215-2455
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Springfield, Illinois 62701
Principal Investigator: Jeff Goldstein, MD
Phone: 217-492-9100
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Tallahassee, Florida 32308
Principal Investigator: Wayne Batchelor, MD
Phone: 850-431-5024
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Tampa, Florida 33613
Principal Investigator: Charles R Lambert, MD
Phone: 813-615-7527
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Tucson, Arizona 85724
Principal Investigator: Ranjith Shetty, MD
Phone: 520-626-5431
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Vancouver, British Columbia
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Winston-Salem, North Carolina 27157
Principal Investigator: David Zhao, MD
Phone: 336-713-4432
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Wormleysburg, Pennsylvania 17043
Principal Investigator: David Pawlush, MD
Phone: 717-920-4400
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