Strategic Management to Optimize Response To Cardiac Resynchronization Therapy



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 1, 2017
End Date:December 2019
Contact:Allison Anderson
Email:Allison.Anderson@bsci.com
Phone:+1 919-345-6001

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The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients
with a prolonged RV-LV interval.


Inclusion Criteria:

- Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac
Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV
lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D
from a previously implanted device.

- In order to achieve a homogenous population for the study, qualifying subjects are
those with heart failure who meet BSC US indications for use defined as those subjects
who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet
any one of the following classifications:

- Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS
duration ≥ 120 ms

- Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild
(NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class
I) ischemic heart failure

- Subject is age 18 or above, or of legal age to give informed consent specific to each
country and national laws

- Subject is willing and capable of providing informed consent

- Subject is willing and capable of complying with visits and procedures as defined by
this protocol

Exclusion Criteria:

- Subjects with documented permanent complete AV block

- Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of
enrollment

- Subjects who have previously received cardiac resynchronization therapy with pacing in
the left ventricle

- Subjects on the active heart transplant list or who has or is to receive ventricular
assist device (VAD)

- Life expectancy shorter than 12 months due to any medical condition (e.g., cancer,
uremia, liver failure, etc…)

- Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)

- Subject is enrolled in any other concurrent clinical study, with the exception of
local mandatory governmental registries and observational studies/registries, without
the written approval from Boston Scientific

- Women of childbearing potential who are or plan to become pregnant during the course
of the trial

- Subjects currently requiring dialysis
We found this trial at
43
sites
Iowa City, Iowa 52242
Principal Investigator: Michael Giudici, MD
Phone: 319-384-2915
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Conor Barrett, MD
Phone: 617-726-5067
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Roderick Tung, MD
Phone: 773-702-0535
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Mohammad Kooshkabadi, MD
Phone: 404-236-8303
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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3690 Grandview Parkway
Birmingham, Alabama 35243
Principal Investigator: Joaquin Arciniegas, MD
Phone: 205-971-7578
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
Principal Investigator: Bharath Reddy
Phone: 718-780-3626
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Burlington, Massachusetts 01805
Phone: 781-744-8863
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Burlington, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: John Sturdivant
Phone: 843-792-2994
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: John Bailey
Phone: 704-264-1400
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111 South Grant Avenue
Columbus, Ohio 43215
Phone: 614-566-9840
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Dallas, Texas
Principal Investigator: Phi Wiegn
Phone: 214-857-1535
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Danville, Pennsylvania 17882
Principal Investigator: Jess Oren
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Edgewood, Kentucky 41017
Principal Investigator: Jon Hays
Phone: 859-331-3353
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Glendale, California 91206
Principal Investigator: John McKenzie, MD
Phone: 818-409-8009
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Haddon Heights, New Jersey 08035
Principal Investigator: George Mark, MD
Phone: 856-546-3003
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Principal Investigator: Hamid Afshar
Phone: 713-791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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Huntsville, Alabama 35801
Principal Investigator: John Jennings
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201 East Oak Avenue
Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, MD
Phone: 870-935-6729
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5525 Grossmont Center Drive
La Mesa, California 91942
Principal Investigator: Alborz Hassankhani, MD
Phone: 619-874-1833
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Lakeland, Florida 33805
Principal Investigator: Kevin Browne
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Lexington, Kentucky 40503
Principal Investigator: Tomassoni Gery, MD
Phone: 859-260-6429
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Missoula, Montana 59802
Principal Investigator: Michael Yerkey, MD
Phone: 406-329-2797
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Newark, Delaware 19713
Principal Investigator: Piamsook Angkeow, MD
Phone: 302-733-4645
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Newburgh, Indiana 47630
Principal Investigator: Chandrashekar Kumbar
Phone: 812-426-9576
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Paramus, New Jersey 07450
Principal Investigator: Suneet Mittal
Phone: 201-432-7837
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Paterson, New Jersey 07503
Principal Investigator: Satish Tiyyagura
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Robert Schaller, MD
Phone: 215-662-3999
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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9205 Southwest Barnes Road
Portland, Oregon 97225
Principal Investigator: Scott Brancato
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Pottstown, Pennsylvania 19464
Principal Investigator: Vadim Levin
Phone: 610-326-8005
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Jayanthi Koneru
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Rochester, New York 14621
Principal Investigator: Abrar Shah
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Roseville, Michigan 48066
Principal Investigator: Ali Shakir
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Saint Paul, Minnesota 55102
Principal Investigator: David Dunbar, MD
Phone: 651-471-2684
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Salinas, California 93901
Principal Investigator: Yuji Saito
Phone: 859-331-3353
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7400 Merton Minter
San Antonio, Texas 78229
Principal Investigator: Manoj Panday
Phone: 210-617-5300
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Sioux Falls, South Dakota 57018
Principal Investigator: Paul Olson, MD
Phone: 605-977-5000
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Springfield, Illinois 62701
Principal Investigator: Ziad Issa, Dr
Phone: 217-492-9100
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Toronto, Onterio
Principal Investigator: Douglas Cameron
Phone: 416 340 4339
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Tucson, Arizona 85724
Principal Investigator: Mathew Hutchinson
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400 NE Mother Joseph Pl
Vancouver, Washington 98664
(360) 256-2000
Principal Investigator: Jonathon Lowry, MD
Phone: 360-514-2016
PeaceHealth Southwest Medical Center n 1858, a pioneering nun, Mother Joseph, opened a hospital that...
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Winston-Salem, North Carolina 27103
Principal Investigator: Lai Chow Kok, MD
Phone: 336-718-6074
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Winter Haven, Florida 33881
Phone: 863-293-1121
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5341 McAuley Drive
Ypsilanti, Michigan 48197
Principal Investigator: Bipib Ravindran, MD
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