MultiPoint Pacing IDE Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 2013
End Date:June 2016

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This IDE study is a prospective, randomized, double-blind, multi-center clinical study to
evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment
with standard BiV pacing at 9 months.

The study will be conducted at a maximum of 50 investigational centers located in the United
States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization
therapy device (CRT-D) system will be enrolled in the study.

All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant,
and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is
programmed using any one of the 10 available pacing vectors. The paced/sensed
atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's
standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up
visit.

At the 3-month visit, responder status between Enrollment and 3 months will be assessed using
the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition
outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened"
or "Unchanged" using the definitions outlined in the CCS will be considered as
Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g.,
Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with
"equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature
on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm
or MPP arm.

At the 9-month visit, responder status will be evaluated once again using the CCS and
compared to the status at 3 months.

Inclusion Criteria:

- Meets current clinical indication for implantation of a cardiac resynchronization
therapy system for treatment of heart failure or life-threatening ventricular
tachyarrhythmia(s)

- Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker
implant with no prior LV lead placement

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

Exclusion Criteria:

- Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA)
within 3 months of enrollment

- Have an existing Class I recalled lead

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

- Have a classification of Status 1 for cardiac transplantation or consideration for
transplantation over the next 9 months

- Have permanent atrial fibrillation (AF)

- Have undergone a cardiac transplantation within 40 days of enrollment

- Have had a recent myocardial infarction, unstable angina within 40 days or cardiac
revascularization within 3 months of implant.

- Are currently participating in a clinical investigation that includes an active
treatment arm

- Are pregnant or planning to become pregnant during the duration of the study

- Have a life expectancy of less than 9 months due to any condition

- Are less than 18 years of age
We found this trial at
49
sites
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
2184
mi
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Charleston, SC
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
2244
mi
from 91732
Rochester, NY
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Albuquerque, New Mexico 87102
649
mi
from 91732
Albuquerque, NM
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Amarillo, Texas 73106
922
mi
from 91732
Amarillo, TX
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Atlanta, Georgia 30324
1920
mi
from 91732
Atlanta, GA
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Austin, Texas 78756
1211
mi
from 91732
Austin, TX
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Brandon, Florida 33511
2144
mi
from 91732
Brandon, FL
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Browns Mills, New Jersey 08015
2406
mi
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Browns Mills, NJ
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Burlington, Massachusetts 01805
2570
mi
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Burlington, MA
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Charlotte, North Carolina 28204
2101
mi
from 91732
Charlotte, NC
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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...
2033
mi
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Cleveland, OH
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Columbus, Ohio 43214
1959
mi
from 91732
Columbus, OH
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
2433
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Englewood, NJ
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14
mi
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Glendale, CA
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Huntsville, Alabama 35801
1785
mi
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Huntsville, AL
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Jackson, Mississippi 39216
1609
mi
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Jackson, MS
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Kansas City, Missouri 64111
1340
mi
from 91732
Kansas City, MO
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La Jolla, California 92037
95
mi
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La Jolla, CA
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Lakeland, Florida 33805
2163
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Lakeland, FL
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Lakewood, Colorado 80228
808
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Lakewood, CO
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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...
2313
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Lancaster, PA
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Lansing, Michigan 48910
1891
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Lansing, MI
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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...
1879
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Lexington, KY
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Little Rock, Arkansas 72211
1456
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Little Rock, AR
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Mesa, Arizona 85206
364
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Mesa, AZ
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Milwaukee, Wisconsin 14450
1729
mi
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Milwaukee, WI
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
2407
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Morristown, NJ
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Nashville, Tennessee 37232
1763
mi
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Nashville, TN
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Nashville, Tennessee 37205
1759
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Nashville, TN
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
1650
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New Orleans, LA
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2434
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New York, NY
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Newark, Delaware 19718
2354
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Newark, DE
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Newport Beach, California 92663
31
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Newport Beach, CA
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Norwalk, Connecticut 06851
2462
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Norwalk, CT
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Orlando, Florida 32803
2184
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Orlando, FL
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Peoria, Illinois 61614
1618
mi
from 91732
Peoria, IL
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
2375
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
2121
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Pittsburgh, PA
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Sacramento, California 95819
364
mi
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Sacramento, CA
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Sacramento, California 95815
367
mi
from 91732
Sacramento, CA
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Saint Louis, Missouri 63141
1573
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Saint Louis, MO
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San Antonio, Texas 78299
1190
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from 91732
San Antonio, TX
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
2148
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Sarasota, FL
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
1934
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Toledo, OH
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Tupelo, Mississippi 38801
1666
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Tupelo, MS
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Virginia Beach, Virginia 23454
2351
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Virginia Beach, VA
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Wausau, Wisconsin 54401
1675
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Wausau, WI
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Winston-Salem, North Carolina 27615
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Winston-Salem, NC
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York, Pennsylvania 17405
2290
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York, PA
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