Quadripolar Pacing Post Approval Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:February 15, 2012
End Date:March 15, 2019

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

The purpose of this post-approval study is to evaluate the acute and chronic performance of a
Quadripolar CRT-D device system in a patient population indicated for cardiac
resynchronization therapy (CRT).

Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion
criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left
ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30
days for any adverse events and then withdrawn from the study, or may have an implant
reattempted if the physician chooses to do so. Patients enrolled in the study will be
followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years).
After patients complete 60 months of follow-up, their participation in the study will be
terminated.

Inclusion Criteria:

1. Approved indication per current American College of Cardiology/American Heart
Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for
treatment of heart failure or life threatening ventricular tachyarrhythmia(s).

2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study
(Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar
CRT-D device system implant or are undergoing an upgrade from an existing implantable
cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.

3. Have the ability to provide informed consent for study participation and be willing
and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

2. Have a life expectancy of less than 5 years due to any condition

3. Be less than 18 years of age
We found this trial at
71
sites
Bangor, Maine 04401
798
mi
from 43215
Bangor, ME
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
344
mi
from 43215
Chapel Hill, NC
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6071 West Outer Drive
Detroit, Michigan 48235
169
mi
from 43215
Detroit, MI
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Ocala, Florida 34471
747
mi
from 43215
Ocala, FL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
414
mi
from 43215
Philadelphia, PA
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
971
mi
from 43215
Weston, FL
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514
mi
from 43215
Albany, NY
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Albuquerque, New Mexico 87106
1331
mi
from 43215
Albuquerque, NM
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Atlanta, Georgia 30309
432
mi
from 43215
Atlanta, GA
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Atlantis, Florida 33462
939
mi
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Atlantis, FL
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Bakersfield, California 93309
1982
mi
from 43215
Bakersfield, CA
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Baltimore, Maryland 21237
349
mi
from 43215
Baltimore, MD
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Bedford, Texas 76021
924
mi
from 43215
Bedford, TX
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Birmingham, Alabama 35211
495
mi
from 43215
Birmingham, AL
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Boynton Beach, Florida 33437
943
mi
from 43215
Boynton Beach, FL
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Browns Mills, New Jersey 08015
446
mi
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Browns Mills, NJ
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Bryn Mawr, Pennsylvania 19010
407
mi
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Bryn Mawr, PA
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
638
mi
from 43215
Burlington, MA
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590
mi
from 43215
Burlington, VT
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Cedar Rapids, Iowa 53402
470
mi
from 43215
Cedar Rapids, IA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
138
mi
from 43215
Cleveland, OH
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Corpus Christi, Texas 78404
1175
mi
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Corpus Christi, TX
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Elyria, Ohio 44035
108
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Elyria, OH
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212
mi
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Erie, PA
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Fargo, North Dakota 58122
837
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Fargo, ND
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Fayetteville, Arkansas 72703
659
mi
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Fayetteville, AR
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Florence, South Carolina 29506
437
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Florence, SC
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Fort Wayne, Indiana 46805
135
mi
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Fort Wayne, IN
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Gastonia, North Carolina 28054
340
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Gastonia, NC
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Haddon Heights, New Jersey 08035
421
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Haddon Heights, NJ
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Harrisonburg, Virginia 22801
245
mi
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Harrisonburg, VA
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Houston, Texas 77024
996
mi
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Houston, TX
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Huntsville, Alabama 35801
409
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Huntsville, AL
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Johnson City, Tennessee 37601
254
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Johnson City, TN
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Kingsport, Tennessee 37660
237
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Kingsport, TN
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La Jolla, California 92037
1953
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La Jolla, CA
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Lake Mary, Florida 32746
780
mi
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Lake Mary, FL
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
353
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Lancaster, PA
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Lansing, Michigan 48910
207
mi
from 43215
Lansing, MI
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Las Vegas, Nevada 89109
1759
mi
from 43215
Las Vegas, NV
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
157
mi
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Lexington, KY
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Little Rock, Arkansas 72211
628
mi
from 43215
Little Rock, AR
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Los Angeles, California 90033
1969
mi
from 43215
Los Angeles, CA
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Memphis, Tennessee 38104
507
mi
from 43215
Memphis, TN
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1612
mi
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Missoula, MT
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Montgomery, Alabama 36116
561
mi
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Montgomery, AL
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Morgantown, West Virginia 26505
164
mi
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Morgantown, WV
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Mountain View, California 94040
2097
mi
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Mountain View, CA
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259
mi
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Munster, IN
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Naples, Florida 34102
958
mi
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Naples, FL
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Nashville, Tennessee 37205
338
mi
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Nashville, TN
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Newport Beach, California 92663
1967
mi
from 43215
Newport Beach, CA
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Northridge, California 91325
1981
mi
from 43215
Northridge, CA
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Oklahoma City, Oklahoma
849
mi
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Oklahoma City, OK
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Omaha, Nebraska 68122
689
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Omaha, NE
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Orange, California 92868
1959
mi
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Orange, CA
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Peoria, Illinois 61614
350
mi
from 43215
Peoria, IL
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Phoenix, Arizona 85006
1661
mi
from 43215
Phoenix, AZ
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Plantation, Florida 33324
970
mi
from 43215
Plantation, FL
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Richmond, Virginia 23225
342
mi
from 43215
Richmond, VA
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Rockville, Maryland 20850
316
mi
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Rockville, MD
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Sacramento, California 95819
2041
mi
from 43215
Sacramento, CA
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
407
mi
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Saint Louis, MO
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Saint Petersburg, Florida 33709
839
mi
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Saint Petersburg, FL
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Salt Lake City, Utah 84132
1510
mi
from 43215
Salt Lake City, UT
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Spokane, Washington 99204
1779
mi
from 43215
Spokane, WA
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Stockton, California 95204
2045
mi
from 43215
Stockton, CA
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100 Nicolls Road
Stony Brook, New York 11794
524
mi
from 43215
Stony Brook, NY
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Ventura, California 93003
2018
mi
from 43215
Ventura, CA
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481
mi
from 43215
Wausau, WI
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Williamsville, New York 14221
303
mi
from 43215
Williamsville, NY
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