QP ExCELs: MultiPole Pacing (MPP) Sub-Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:May 19, 2017
End Date:December 1, 2019
Contact:Karlene Cox
Email:QPstudyteam@biotronik.com
Phone:800-547-0394

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The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to
demonstrate that the MPP feature is effective by converting a percentage of cardiac
resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a
single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).


Inclusion Criteria:

- Currently enrolled in the ongoing QP ExCELs study

- Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or
future-marketed CRT-D system with the MPP feature. Successful implantation is defined
as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @
any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve
stimulation at the final programmed pacing output at the time of enrollment into the
MPP sub-study.

- CRT Responder Assessment classification as "Worsened" or "Unchanged"

- Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP
ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a
HF hospitalization event)

- Able to understand the nature of the sub-study and give informed consent

- Available for an additional follow-up visit specific to the MPP sub-study at the
investigational site

- No evidence of non-compliance to their ongoing commitment in the QP ExCELs study

Exclusion Criteria:

- Have a life expectancy of less than 6 months

- Expected to receive heart transplantation or ventricular assist device within 6 months

- Chronic atrial fibrillation

- Presence of another life-threatening, underlying illness separate from their cardiac
disorder

- Received MPP pacing prior to enrolment into the MPP sub-study
We found this trial at
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San Antonio, Texas 78229
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Amarillo, Texas 79106
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3831 Piper Street
Anchorage, Alaska 99508
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100 Healthy Way
Anderson, South Carolina 29621
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Ann Arbor, Michigan 48109
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Asheville, North Carolina 28802
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Atlanta, Georgia 30309
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Aurora, Colorado 80012
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Bangor, Maine 04401
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Browns Mills, New Jersey 08015
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Burlington, Massachusetts 01805
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192 Tilley Drive
Burlington, Vermont 05403
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Chattanooga, Tennessee 37403
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Cheyenne, Wyoming
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Chula Vista, California 91911
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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8 Richland Medical Park Drive
Columbia, South Carolina 29203
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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3705 Olentangy River Road
Columbus, Ohio 43214
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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362 Prospect Street
Fall River, Massachusetts 02720
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
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Flushing, New York 11355
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11108 Parkview Plaza Drive
Fort Wayne, Indiana 46845
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1900 Mistletoe Boulevard
Fort Worth, Texas 76104
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1126 North Church Street
Greensboro, North Carolina 27401
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115 Heart Drive
Greenville, North Carolina 27834
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Greenville, South Carolina 29607
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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323 North Prairie Avenue
Inglewood, California 90301
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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350 Heritage Way
Kalispell, Montana 59901
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Kansas City, Kansas 66160
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Lexington, Kentucky 40503
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Lexington, Kentucky
859) 257-9000
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Milwaukee, Wisconsin 53215
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Mobile, Alabama 36608
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Neptune, New Jersey 07754
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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1111 Amsterdam Avenue
New York, New York 10025
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New York, New York 10065
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403 East 34th Street
New York, New York 10016
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
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Orlando, Florida 32806
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1717 North E Street
Pensacola, Florida 32501
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3401 North Broad Street
Philadelphia, Pennsylvania 19140
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Rancho Mirage, California 92270
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300 1st Capitol Drive
Saint Charles, Missouri 63301
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Saint Louis, Missouri 63136
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Salt Lake City, Utah 84132
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2115 South Fremont Avenue
Springfield, Missouri 65804
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7000 Fannin Street
The Woodlands, Texas 77384
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Toledo, Ohio 43615
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Toledo, Ohio 43608
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Valhalla, New York 10595
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Washington, District of Columbia
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Winston-Salem, North Carolina 27157
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186 Kimel Park Drive
Winston-Salem, North Carolina 27103
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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Wynnewood, Pennsylvania 19096
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Ypsilanti, Michigan 48197
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