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

Status: Terminated
Location: See all (68) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Treatment of ischemic heart failure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: No
View:

• 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:

Locations
United States
Arkansas
Arkansas Heart
Little Rock
Arizona
Arizona Heart
Phoenix
University of Arizona Medical Center
Tucson
California
Cedars-Sinai Medical Center
Los Angeles
University of Southern California (USC)
Los Angeles
UC Davis Medical Center
Sacramento
Florida
Morton Plant Hospital - Heart and Vascular Institute of Florida
Clearwater
Delray Medical Center
Delray Beach
Tallahassee Research Institute
Tallahassee
Florida Hospital Tampa - Pepin Heart Institute
Tampa
Georgia
Piedmont Atlanta Hospital
Atlanta
Iowa
Iowa Heart Center
Des Moines
University of Iowa Hospitals and Clinics
Iowa City
Idaho
Kootenai Heart Clinics
Coeur D'alene
Illinois
Evanston Hospital
Evanston
Advocate Medical Group - Midwest Heart Foundation
Naperville
Prairie Education and Research Cooperative - St. John's Hospital
Springfield
Indiana
St. Vincent Heart Center of Indiana
Indianapolis
Kansas
University of Kansas Hospital
Kansas City
Kentucky
Baptist Health Lexington
Lexington
St Joseph Hospital/Kentucky One
Lexington
Jewish Hospital/Louisville
Louisville
Louisiana
Cardiovascular Institute of the South
Houma
LSU Health Sciences Center
New Orleans
Ochsner Clinic Foundation
New Orleans
Massachusetts
Tufts Medical Center
Boston
Maryland
University of Maryland Medical Center
Baltimore
Michigan
St. Joseph Mercy-Michigan Heart
Ann Arbor
MidMichigan Medical Center
Midland
Minnesota
University of Minnesota Medical Center
Minneapolis
United Heart and Vascular Clinic
Saint Paul
Missouri
St. Luke's MAHI
Kansas City
North Carolina
Wake Forest Baptist Health
Winston-salem
Nebraska
Nebraska Heart Hospital
Lincoln
New Jersey
Deborah Heart and Lung Center
Browns Mills
Hackensack UMC
Hackensack
New York
Gates Vascular Institute/Buffalo General Hospital
Buffalo
Mount Sinai Medical Center
New York
New York Presbyterian Hospital - Cornell Campus
New York
Univ. Of Rochester Medical Center
Rochester
Ohio
The Christ Hospital Lindner Research Center
Cincinnati
University Hospitals
Cleveland
Ohio Health Research Institute/Riverside Methodist Hospital
Columbus
The Ohio State University
Columbus
Oklahoma
Integris Baptist Medical Center
Oklahoma City
Oklahoma Heart Hospital
Oklahoma City
Pennsylvania
Lancaster General Hospital
Lancaster
Einstein Healthcare Network Cardiology
Philadelphia
Hospital of the University of Pennsylvania
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Medical Center - Presbyterian Hospital
Pittsburgh
Pinnacle Health Cardiovascular Institute
Wormleysburg
Rhode Island
The Miriam Hospital
Providence
Tennessee
Wellmont Holston Valley Medical Center
Kingsport
Tennova Healthcare - Turkey Creek Medical Center
Knoxville
Saint Thomas West Hospital
Nashville
Vanderbilt University
Nashville
Texas
Texas Cardiac Arrhythmia Research Foundation
Austin
Memorial Hermann Hospital
Houston
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston
The Methodist Hospital
Houston
Utah
University of Utah
Salt Lake City
Virginia
Inova Heart and Vascular, Fairfax
Falls Church
Sentara Cardiovascular Research Institute
Norfolk
Virginia Commonwealth University Medical Center
Richmond
Washington
Swedish Medical Center
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Other Locations
Canada
St. Paul's Hospital
Vancouver
Time Frame
Start Date: December 2012
Completion Date: June 2017
Participants
Target number of participants: 331
Treatments
Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT)
No Intervention: All Appropriate Medical Therapy (AAMT)
Authors
Freddie Williams, George Chrysant, J. Stephen Jenkins, Gautam Kumar, George Dangas, Nezar Falluji, Phillip Horwitz, Hector Ventura, Gery Tomassoni, Rupal P. Dumasia, Bilal Murad, Charles R Lambert, Keyur Shah, Joseph Gelormini, David Zhao, Srinivas Murali, Emerson Perin, Gina Mentzer, William Lindsay, Arthur M. Szyniszewski, Lee W. Jordan, Peter Fail, James Fang, Joyce W. Wald, Nasir Sulemanjee, Marc Simon, Mukta Srivastava, Shashank Desai, Daniel Simon, James Hermiller, Dean Kereiakes, Paul Mahoney, Jon Kobashigawa, David M. Mego, Brijeshwar Maini, Kumar Satya, Steven J. Yakubov, Mark Friedman, Thomas Deering, Catalin Toma, Shahram Yazdani, Marco A Costa, Daniel Levine, Frank Smart, Ronald D Jenkins, Wayne Batchelor, Suhail Allaqaband, Mark Goodwin, Garrie J Haas, Ziad Issa, Akash Ghai, Paul Huang, Mark Stampehl, Jeffrey Goodman, John Scherschel, Paul Gordon, Neal S. Kleiman, Marlo F. Leonen, William Wickemeyer, Vijendra Swarup, Don Chomsky, Carl J. Leding, Eugene Chung, Jon George, Vladimir Cotarlan, Michael Morse, Michael Flaherty, Andrzej Boguszewski, Michael Lauer, Navin Kapur, Randall Genton, David Pawlush, Miguel Valderrabano, Mark Wiley, Andrew Civitello, Saibal Kar, Ranjith Shetty, David Denofrio, Chirag Sandesara, Emil D Missov, John Dieck, Oana Petrescu, Zachary Gertz, Ted Feldman, Justin Roberts, Allen Ciuffo, Richard Abben, Richard Kovach, Michael Schaeffer, Gladwin Suseekar Das, Evelyn Horn, Ebere Chukwu, Michael Shehata, Sameer Jamal, Hemal Gada, Leway Chen, Sriram Nathan, Kelly McCants, Howard C. Herrmann, Rodney Horton, Emma Birks, Rahul Doshi, Jihn Han, Ernest Mazzaferri, Vivek Rajagopal, Alan Bank, Mark Tannenbaum, Malcolm T. Foster, Anwar Tandar, Patrick Cambier, David Shavelle, Maria Rosa Costanzo, Sean Pinney, Leslie Saxon, Gautam Ramani, Guilherme H Oliveira, Timothy J Lessmeier, Rakesh K Sharma, Mark Moshiyakov, Mary Walsh, Andrew Yoon, John Zimmerman, Christopher Metzger, Jerry Estep, Douglas Horstmanshof, Timm-Michael Dickfeld, Frederik Ling, Jeff Goldstein, Madhu Reddy, Steve Smart, Bijwajit Kar, Andrew Kao, Dhanunjaya Lakkireddy, Murtuza J. Ali, William T Abraham, Steven Martin, S. Chiu Wong, Dave Lasorda
Related Therapeutic Areas
Sponsors
Leads: CardioKinetix, Inc

This content was sourced from clinicaltrials.gov

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