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
Sacramento, California 95815
1280
mi
from
Sacramento, CA
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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...
1121
mi
from
Rochester, NY
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Albuquerque, New Mexico 87102
523
mi
from
Albuquerque, NM
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Amarillo, Texas 73106
283
mi
from
Amarillo, TX
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Atlanta, Georgia 30324
801
mi
from
Atlanta, GA
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Austin, Texas 78756
513
mi
from
Austin, TX
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Brandon, Florida 33511
1123
mi
from
Brandon, FL
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Browns Mills, New Jersey 08015
1256
mi
from
Browns Mills, NJ
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Burlington, Massachusetts 01805
1438
mi
from
Burlington, MA
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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...
1063
mi
from
Charleston, SC
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Charlotte, North Carolina 28204
957
mi
from
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...
898
mi
from
Cleveland, OH
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Columbus, Ohio 43214
810
mi
from
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...
1288
mi
from
Englewood, NJ
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1167
mi
from
Glendale, CA
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Huntsville, Alabama 35801
660
mi
from
Huntsville, AL
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Jackson, Mississippi 39216
573
mi
from
Jackson, MS
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Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
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La Jolla, California 92037
1145
mi
from
La Jolla, CA
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Lakeland, Florida 33805
1136
mi
from
Lakeland, FL
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Lakewood, Colorado 80228
417
mi
from
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...
1163
mi
from
Lancaster, PA
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Lansing, Michigan 48910
776
mi
from
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...
724
mi
from
Lexington, KY
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Little Rock, Arkansas 72211
365
mi
from
Little Rock, AR
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Mesa, Arizona 85206
836
mi
from
Mesa, AZ
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Milwaukee, Wisconsin 14450
636
mi
from
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,...
1262
mi
from
Morristown, NJ
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Nashville, Tennessee 37232
618
mi
from
Nashville, TN
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Nashville, Tennessee 37205
615
mi
from
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...
694
mi
from
New Orleans, LA
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1289
mi
from
New York, NY
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Newark, Delaware 19718
1202
mi
from
Newark, DE
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Newport Beach, California 92663
1161
mi
from
Newport Beach, CA
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Norwalk, Connecticut 06851
1319
mi
from
Norwalk, CT
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Orlando, Florida 32803
1141
mi
from
Orlando, FL
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Peoria, Illinois 61614
486
mi
from
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...
1225
mi
from
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...
974
mi
from
Pittsburgh, PA
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Sacramento, California 95819
1280
mi
from
Sacramento, CA
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Saint Louis, Missouri 63141
418
mi
from
Saint Louis, MO
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San Antonio, Texas 78299
575
mi
from
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...
1143
mi
from
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...
801
mi
from
Toledo, OH
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Tupelo, Mississippi 38801
561
mi
from
Tupelo, MS
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Virginia Beach, Virginia 23454
1196
mi
from
Virginia Beach, VA
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Wausau, Wisconsin 54401
652
mi
from
Wausau, WI
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Winston-Salem, North Carolina 27615
?
mi
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Winston-Salem, NC
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York, Pennsylvania 17405
1140
mi
from
York, PA
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