Study Results
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View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2017-05-19
2020-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.
Interventions
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MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.
Eligibility Criteria
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Inclusion Criteria
* 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 Heart Failure (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
* 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
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Thomas Hospital
Fairhope, Alabama, United States
South Bay Electrophysiology
Inglewood, California, United States
Eisenhower Desert Cardiology
Rancho Mirage, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Orlando Health Heart Institute
Orlando, Florida, United States
Florida Hospital Tampa Pepin Heart Institute
Tampa, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Parkview Physicians Group - Cardiology
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health - Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Northeast Cardiology
Bangor, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Southcoast Health
Fall River, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
SSM Health St. Joseph Hospital - St. Charles
Saint Charles, Missouri, United States
Mercy Clinic Cardiology
Springfield, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Glacier View Medical Research Institute, Cardiology
Kalispell, Montana, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Presbyterian Queens
Flushing, New York, United States
Weill Cornell Medicine
New York, New York, United States
Mt. Sinai St. Luke's Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Novant Health Winston-Salem Cardiology
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health Medical Center
Winston-Salem, North Carolina, United States
Sanford Medical Center - Fargo
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Temple Heart and Vascular Institute
Philadelphia, Pennsylvania, United States
Upstate Cardiology
Greenville, South Carolina, United States
UT Erlanger Cardiology
Chattanooga, Tennessee, United States
Fort Worth Heart
Fort Worth, Texas, United States
UT Health Science Center
The Woodlands, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
UVM Medical
Burlington, Vermont, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MPP Sub-Study
Identifier Type: -
Identifier Source: org_study_id
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