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
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...
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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...
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Albuquerque, New Mexico 87102
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Amarillo, Texas 73106
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Atlanta, Georgia 30324
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Austin, Texas 78756
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Brandon, Florida 33511
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Browns Mills, New Jersey 08015
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Burlington, Massachusetts 01805
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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...
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Charlotte, North Carolina 28204
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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...
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Columbus, Ohio 43214
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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...
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Glendale, CA
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Huntsville, Alabama 35801
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Jackson, Mississippi 39216
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Kansas City, Missouri 64111
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La Jolla, California 92037
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Lakeland, Florida 33805
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Lakewood, Colorado 80228
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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...
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Lansing, Michigan 48910
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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...
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Little Rock, Arkansas 72211
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Mesa, Arizona 85206
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Milwaukee, Wisconsin 14450
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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,...
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Nashville, Tennessee 37232
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Nashville, Tennessee 37205
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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...
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Newark, Delaware 19718
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Newport Beach, California 92663
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Norwalk, Connecticut 06851
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Orlando, Florida 32803
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Peoria, Illinois 61614
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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...
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Sacramento, California 95819
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Sacramento, California 95815
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Saint Louis, Missouri 63141
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San Antonio, Texas 78299
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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...
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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...
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Tupelo, Mississippi 38801
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Virginia Beach, Virginia 23454
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Wausau, Wisconsin 54401
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Winston-Salem, North Carolina 27615
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York, Pennsylvania 17405
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