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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by CardioKinetix, Inc
Information provided by (Responsible Party):
CardioKinetix, Inc Identifier:
First received: June 4, 2012
Last updated: March 24, 2017
Last verified: March 2017
Treatment of ischemic heart failure.

Condition Intervention Phase
Congestive Heart Failure
Left Ventricular (LV) Systolic Dysfunction
Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Resource links provided by NLM:

Further study details as provided by CardioKinetix, Inc:

Primary Outcome Measures:
  • Death or re-hospitalization for Worsening Heart Failure (WHF) [ Time Frame: At least 1 year ]

Estimated Enrollment: 560
Study Start Date: December 2012
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT) Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
No Intervention: All Appropriate Medical Therapy (AAMT)


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01614652

Contact: Ritu Verma 650-618-7918
Contact: Tanya Singh

  Hide Study Locations
United States, Arizona
Arizona Heart Recruiting
Phoenix, Arizona, United States, 85013
Contact: Courtney Rothwell    602-456-2342   
Principal Investigator: Vijendra Swarup, MD         
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Sobedya Lizette Marquez    520-626-5431   
Principal Investigator: Ranjith Shetty, MD         
Principal Investigator: Mark Friedman, MD         
United States, Arkansas
Arkansas Heart Recruiting
Little Rock, Arkansas, United States, 72211
Contact: James Bellamy    501-748-8441   
Principal Investigator: Carl J. Leding, MD         
Principal Investigator: David M. Mego, MD         
United States, California
University of Southern California (USC) Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Minor    323-442-7983   
Principal Investigator: Rahul Doshi, MD         
Principal Investigator: David Shavelle, MD         
Principal Investigator: Andrew Yoon, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90069
Contact: Mane Arabyan    310-248-8515   
Principal Investigator: Saibal Kar, MD         
Principal Investigator: Jon Kobashigawa, MD         
Principal Investigator: Michael Shehata, MD         
Principal Investigator: Jeffrey Goodman, MD         
UC Davis Medical Center Completed
Sacramento, California, United States, 95817
United States, Connecticut
Yale-New Haven Hospital Withdrawn
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Hospital Center Withdrawn
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital - Heart and Vascular Institute of Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: Sue Fisher    727-723-6511   
Principal Investigator: Rakesh K Sharma, MD         
Delray Medical Center Recruiting
Delray Beach, Florida, United States, 33444
Contact: Christine Dacosta    561-495-3228   
Principal Investigator: Brijeshwar Maini         
Tallahassee Research Institute Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Knap    850-431-5024   
Principal Investigator: Wayne Batchelor, MD         
Principal Investigator: Akash Ghai, MD         
Florida Hospital Tampa - Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Cynthia Paysor    813-615-7527   
Principal Investigator: Charles R Lambert, MD         
United States, Georgia
Emory University Hospital Midtown Withdrawn
Atlanta, Georgia, United States, 30308
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Caryn Bernstein    404-605-6517   
Principal Investigator: Vivek Rajagopal         
Principal Investigator: Kelly McCants         
Principal Investigator: Thomas Deering         
Emory University Hospital Withdrawn
Atlanta, Georgia, United States, 30322
United States, Idaho
Kootenai Heart Clinics Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact: Shamela Barnett    208-676-9913 ext 638   
Principal Investigator: Ronald D Jenkins, MD         
Principal Investigator: Timothy J Lessmeier, MD         
United States, Illinois
Northwestern University Withdrawn
Chicago, Illinois, United States, 60611
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Lisa Smalley    847-570-2366   
Principal Investigator: Ted Feldman, MD         
Principal Investigator: Steve Smart, MD         
Advocate Medical Group - Midwest Heart Foundation Recruiting
Naperville, Illinois, United States, 60566
Contact: Josilyn Klimek    630-873-3405   
Principal Investigator: Mark Goodwin, MD         
Principal Investigator: Maria Rosa Costanzo, MD         
Prairie Education and Research Cooperative - St. John's Hospital Recruiting
Springfield, Illinois, United States, 62701
Contact: Lauren Bainter    217-492-9100 ext 142   
Principal Investigator: Jeff Goldstein, MD         
Principal Investigator: Mark Stampehl, MD         
Principal Investigator: Ziad Issa, MD         
Principal Investigator: John Scherschel, MD         
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Regina Margiotti    317-338-6151   
Principal Investigator: James Hermiller, MD         
Principal Investigator: Mary Walsh, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
Contact: Michelle Fopma    515-235-5114   
Principal Investigator: Mark Tannenbaum, MD         
Principal Investigator: William Wickemeyer, MD         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242-1081
Contact: Page Scovel    319-384-8005   
Principal Investigator: Phillip Horwitz, MD         
Principal Investigator: Vladimir Cotarlan, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Melissa Jaeger    913-588-9627   
Principal Investigator: Mark Wiley, MD         
Principal Investigator: Randall Genton, MD         
Principal Investigator: Dhanunjaya Lakkireddy, MD         
Principal Investigator: Madhu Reddy, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Feather Wafford    859-260-6066    feather.wafford@BHSI.COM   
Contact: Julie Ayers    859-260-4484   
Principal Investigator: Gery Tomassoni, MD         
St Joseph Hospital/Kentucky One Recruiting
Lexington, Kentucky, United States, 40504
Contact: Shannon Hibbits    859-313-4161   
Principal Investigator: Nezar Falluji, MD         
Principal Investigator: Michael Schaeffer, MD         
Jewish Hospital/Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Shari Williams    502-407-3259   
Principal Investigator: Michael Flaherty         
Principal Investigator: Emma Birks         
Norton Cardiovascular Withdrawn
Louisville, Kentucky, United States, 40202
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Vicky Parfait    985-873-5613   
Principal Investigator: Peter Fail, MD         
Principal Investigator: Richard Abben, MD         
LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Cris Molina    504-568-2349   
Contact: Jacob Simon   
Principal Investigator: Frank Smart, MD         
Principal Investigator: Murtuza J. Ali, MD         
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cristine Hardy    504-842-6832   
Principal Investigator: J. Stephen Jenkins, MD         
Principal Investigator: Hector Ventura, MD         
United States, Maryland
University of Maryland Medical Center Completed
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Ryan O'Kelly    617-636-4990   
Principal Investigator: Navin Kapur, MD         
Principal Investigator: David Denofrio, MD         
United States, Michigan
St. Joseph Mercy-Michigan Heart Recruiting
Ann Arbor, Michigan, United States, 48197
Contact: Kristy Wippler    734-712-7602   
Principal Investigator: Marlo F. Leonen, MD         
Principal Investigator: Arthur M. Szyniszewski, MD         
Principal Investigator: Jihn Han, MD         
MidMichigan Medical Center Recruiting
Midland, Michigan, United States, 48670
Contact: Jamie Prior    989-631-2469   
Principal Investigator: Andrzej Boguszewski, MD         
Principal Investigator: Michael Lauer, MD         
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily Caldwell    612-626-3656   
Principal Investigator: Gladwin Suseekar Das, MD         
Principal Investigator: Emil D Missov, MD         
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Abbey Arndt    651-241-2811   
Principal Investigator: Bilal Murad, MD         
Principal Investigator: Alan Bank, MD         
United States, Missouri
St. Luke's MAHI Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jackie Smith    816-932-1627   
Principal Investigator: Andrew Kao, MD         
Mercy Hospital St. Louis Withdrawn
St. Louis, Missouri, United States, 63141
United States, Nebraska
Nebraska Heart Hospital Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Corey Godfrey    402-328-3930   
Principal Investigator: Steven Martin, MD         
Principal Investigator: Gina Mentzer, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Lisa Cruser    609-893-5028 ext 5028   
Principal Investigator: Richard Kovach, MD         
Principal Investigator: Mark Moshiyakov, MD         
Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Jana Tancredi    551-996-2353   
Principal Investigator: Kumar Satya         
Principal Investigator: Sameer Jamal         
Principal Investigator: John Zimmerman         
Morristown Medical Center Withdrawn
Morristown, New Jersey, United States, 07960
United States, New York
Gates Vascular Institute/Buffalo General Hospital Recruiting
Buffalo, New York, United States, 14203
Contact: Elizabeth Hejna    716-835-2966   
Principal Investigator: Joseph Gelormini, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Hugo Bloise    212-241-8228   
Principal Investigator: George Dangas, MD         
Principal Investigator: Sean Pinney, MD         
New York Presbyterian Hospital - Cornell Campus Recruiting
New York, New York, United States, 10065
Contact: Melissa Ricketts   
Principal Investigator: S. Chiu Wong, MD         
Principal Investigator: Evelyn Horn, MD         
Lenox Hill Hospital North Shore Withdrawn
New York, New York, United States, 10075
Univ. Of Rochester Medical Center Recruiting
Rochester, New York, United States, 14643
Contact: Angela Klim    585-273-5427   
Principal Investigator: Frederik Ling         
Principal Investigator: Leway Chen         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Amanda Morgan    336-713-4432   
Principal Investigator: David Zhao, MD         
Principal Investigator: Ebere Chukwu, MD         
United States, Ohio
The Christ Hospital Lindner Research Center Recruiting
Cincinnatti, Ohio, United States, 45219
Contact: Roxanne Robertson    513-585-1777   
Principal Investigator: Eugene Chung, MD         
Principal Investigator: Dean Kereiakes, MD         
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nadine Norton    216-844-2636   
Principal Investigator: Daniel Simon, MD         
Principal Investigator: Guilherme H Oliveira, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Shawna Oxier    614-247-6797   
Principal Investigator: Ernest Mazzaferri, MD         
Principal Investigator: Garrie J Haas, MD         
Ohio Health Research Institute/Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Martha Slyman    614-566-1274   
Principal Investigator: Lee W. Jordan, MD         
Principal Investigator: Steven J. Yakubov, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Miki Thompson    405-951-2894   
Principal Investigator: George Chrysant, MD         
Principal Investigator: Douglas Horstmanshof, MD         
Oklahoma Heart Hospital Completed
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17062
Contact: Heidi Testa    717-544-1777   
Principal Investigator: Justin Roberts, DO         
Principal Investigator: Rupal P. Dumasia, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Edith Fletcher    215-662-6590   
Principal Investigator: Joyce W. Wald, MD         
Principal Investigator: Howard C. Herrmann, MD         
Einstein Healthcare Network Cardiology Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Kinnari Murthy    215-456-1959    MurthyK@Einstein.Edu   
Contact: Renee Billingslea    215-456-7054   
Principal Investigator: Jon George, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Kenneth Rayl    412-359-6860   
Principal Investigator: Dave Lasorda, MD         
Principal Investigator: Srinivas Murali, MD         
University of Pittsburgh Medical Center - Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laurie Dennis    412-647-6210   
Principal Investigator: Catalin Toma, MD         
Principal Investigator: Marc Simon, MD         
Pinnacle Health Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise, RN    717-920-4400 ext 4280   
Principal Investigator: David Pawlush, MD         
Principal Investigator: Hemal Gada, MD         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Catherine Gordon    401-793-4105   
Principal Investigator: Paul Gordon, MD         
Principal Investigator: Daniel Levine, MD         
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Brandy Venable    423-230-5618   
Principal Investigator: Christopher Metzger, MD         
Principal Investigator: Freddie Williams, MD         
Tennova Healthcare - Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Linda Doughty    865-218-7539   
Principal Investigator: Malcolm T. Foster, MD         
Principal Investigator: William Lindsay, MD         
Saint Thomas West Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Judy McCarthy    615-222-3862   
Principal Investigator: Michael Morse, MD         
Principal Investigator: Don Chomsky, MD         
Vanderbilt University Completed
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78745
Contact: Deb Cardinal    512-458-9410   
Principal Investigator: John Dieck, MD         
Principal Investigator: Rodney Horton, MD         
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Nazanin Zarinkamar    713-500-7575   
Principal Investigator: Bijwajit Kar, MD         
Principal Investigator: Sriram Nathan, MD         
Texas Heart Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: James Chen    832-355-9366   
Principal Investigator: Emerson Perin, MD         
Principal Investigator: Andrew Civitello, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77056
Contact: Patricia Brinegar    713-363-7995   
Contact: Lisa Green   
Principal Investigator: Neal S. Kleiman, MD         
Principal Investigator: Jerry Estep, MD         
Principal Investigator: Miguel Valderrabano, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ashlee Rooks    801-585-7295   
Principal Investigator: James Fang, MD         
Principal Investigator: Anwar Tandar, MD         
United States, Virginia
Inova Heart and Vascular, Fairfax Recruiting
Falls Church, Virginia, United States, 22042
Contact: Perry Montgomery    703-776-6007   
Principal Investigator: Shahram Yazdani, MD         
Principal Investigator: Shashank Desai, MD         
Principal Investigator: Chirag Sandesara, MD         
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Tina Calayo    757-388-1568   
Principal Investigator: Allen Ciuffo, MD         
Principal Investigator: Paul Mahoney, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Sears    804-828-1601   
Principal Investigator: Zachary Gertz, MD         
Principal Investigator: Keyur Shah, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Charlene Boisjolie    206-215-2455   
Principal Investigator: Paul Huang, MD         
Principal Investigator: Oana Petrescu, MD         
University of Washington Medical Center Withdrawn
Seattle, Washington, United States, 98195
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Maggie Miller    414-385-1853   
Principal Investigator: Suhail Allaqaband, MD         
Principal Investigator: Nasir Sulemanjee, MD         
Canada, British Columbia
St. Paul's Hospital Completed
Vancouver, British Columbia, Canada, V6E 1M7
Sponsors and Collaborators
CardioKinetix, Inc
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CardioKinetix, Inc Identifier: NCT01614652     History of Changes
Other Study ID Numbers: VA0956
Study First Received: June 4, 2012
Last Updated: March 24, 2017

Keywords provided by CardioKinetix, Inc:
Congestive Heart Failure Due to LV Systolic Dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 27, 2017