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

Use our guide to learn which trials are right for you!

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
Newark, Delaware 19713
Principal Investigator: Piamsook Angkeow, MD
Phone: 302-733-4645
?
mi
from
Newark, DE
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Conor Barrett, MD
Phone: 617-726-5067
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3690 Grandview Parkway
Birmingham, Alabama 35243
Principal Investigator: Joaquin Arciniegas, MD
Phone: 205-971-7578
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burlington, Massachusetts 01805
Phone: 781-744-8863
?
mi
from
Burlington, MA
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Principal Investigator: John Bailey
Phone: 704-264-1400
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
111 South Grant Avenue
Columbus, Ohio 43215
Phone: 614-566-9840
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas
Principal Investigator: Phi Wiegn
Phone: 214-857-1535
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danville, Pennsylvania 17882
Principal Investigator: Jess Oren
?
mi
from
Danville, PA
Click here to add this to my saved trials
Edgewood, Kentucky 41017
Principal Investigator: Jon Hays
Phone: 859-331-3353
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
Glendale, California 91206
Principal Investigator: John McKenzie, MD
Phone: 818-409-8009
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
Principal Investigator: George Mark, MD
Phone: 856-546-3003
?
mi
from
Haddon Heights, NJ
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
Principal Investigator: John Jennings
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Iowa City, Iowa 52242
Principal Investigator: Michael Giudici, MD
Phone: 319-384-2915
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
201 East Oak Avenue
Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, MD
Phone: 870-935-6729
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
5525 Grossmont Center Drive
La Mesa, California 91942
Principal Investigator: Alborz Hassankhani, MD
Phone: 619-874-1833
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lakeland, Florida 33805
Principal Investigator: Kevin Browne
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Lexington, Kentucky 40503
Principal Investigator: Tomassoni Gery, MD
Phone: 859-260-6429
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Missoula, Montana 59802
Principal Investigator: Michael Yerkey, MD
Phone: 406-329-2797
?
mi
from
Missoula, MT
Click here to add this to my saved trials
Newburgh, Indiana 47630
Principal Investigator: Chandrashekar Kumbar
Phone: 812-426-9576
?
mi
from
Newburgh, IN
Click here to add this to my saved trials
Paramus, New Jersey 07450
Principal Investigator: Suneet Mittal
Phone: 201-432-7837
?
mi
from
Paramus, NJ
Click here to add this to my saved trials
Paterson, New Jersey 07503
Principal Investigator: Satish Tiyyagura
?
mi
from
Paterson, NJ
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
9205 Southwest Barnes Road
Portland, Oregon 97225
Principal Investigator: Scott Brancato
?
mi
from
Portland, OR
Click here to add this to my saved trials
Pottstown, Pennsylvania 19464
Principal Investigator: Vadim Levin
Phone: 610-326-8005
?
mi
from
Pottstown, PA
Click here to add this to my saved trials
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...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14621
Principal Investigator: Abrar Shah
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Roseville, Michigan 48066
Principal Investigator: Ali Shakir
?
mi
from
Roseville, MI
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
Principal Investigator: David Dunbar, MD
Phone: 651-471-2684
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Salinas, California 93901
Principal Investigator: Yuji Saito
Phone: 859-331-3353
?
mi
from
Salinas, CA
Click here to add this to my saved trials
7400 Merton Minter
San Antonio, Texas 78229
Principal Investigator: Manoj Panday
Phone: 210-617-5300
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sioux Falls, South Dakota 57018
Principal Investigator: Paul Olson, MD
Phone: 605-977-5000
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Springfield, Illinois 62701
Principal Investigator: Ziad Issa, Dr
Phone: 217-492-9100
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Toronto, Onterio
Principal Investigator: Douglas Cameron
Phone: 416 340 4339
?
mi
from
Toronto,
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Mathew Hutchinson
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
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...
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Lai Chow Kok, MD
Phone: 336-718-6074
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Winter Haven, Florida 33881
Phone: 863-293-1121
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials
5341 McAuley Drive
Ypsilanti, Michigan 48197
Principal Investigator: Bipib Ravindran, MD
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials